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June 2016

Conference on why FDA at my Facility is, and what do I do During an Inspection

June 21 - July 22, 2016

WILL BE ANNOUNCED SOON , Zurich, Switzerland , CA, Switzerland

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Who will benefit: Industries • FDA regulated Industries o Medical Device o Pharmaceuticals o Clinical • Dietary Supplements o Food o Nutraceutical • Healthcare IT o Technical Services o Validation o Engineering Departments • Top and Middle Management • Quality Assurance/Management • Compliance Management • Manufacturing • Laboratory • Regulatory Affairs • Information Technology • Marketing & Sales • Operations • Research & Development Types of facilities: • Manufacturing facilities • Contract manufacturing facilities • Distributors • Packaging, Labeling • API Suppliers • Laboratories • Importers • Documentation Management Agenda: Day 1 Schedule Lecture 1: How a firm should prepare for an FDA inspection Lecture 2: Ways to train employees in view of the inspection Lecture 3: How to ensure that required documentation is in place Lecture 4: How to interact with the investigator-DO's and DON'T's Lecture 5: What companies should do when the inspection ends Lecture 6: How to reply to 483's and warning letters Lecture 7: Legal implications of non-compliance Lecture 8: Post inspection actions Day 2 Schedule Lecture 1: Why inspections are conducted and by what statutory authority Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Lecture 3: What is subject to FDA purview and what's off-limits Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key Lecture 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Location: Zurich, Switzerland Date: July 21st and 22nd, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 19, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate - With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 19, Regular Price: $2,295.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900549SEMINAR Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


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July 2016

Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)

July 4-5, 2016

Venue to be announced shortly, Shanghai, Non-U.S., China

Attend this workshop in China to learn new GDP guideline by PIC/S. You will also learn GDP applications, GDP (GWP) regulations, GDP guidelines, cold chain management and risk management. This course will be taught in Chinese language.


DCAT Sharp Sourcing 2016

July 12-12, 2016

Hyatt Regency Hotel, New Brunswick, NJ, United States

What does it take to move Sourcing and Procurement Organizations to the next level? How can pharmaceutical companies, contract service providers, and suppliers collaborate for mutual long-term gain? The answers to these questions will be addressed at DCAT Sharp Sourcing 2016, a conference and networking event that provides peer and customer insight on the best practices and practical ways for optimizing pharmaceutical manufacturing and supply networks. Presented by the Drug, Chemical & Associated Technologies Association (DCAT), the event is designed for senior to mid-level executives engaged in sourcing, purchasing, procurement, supply management, and external manufacturing and their business counterparts on the supply side.


FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies

July 14-15, 2016

Venue to be announced shortly, Irvane, CA, United States

This seminar will teach you the use of stem cells in medicine. You will learn fundamentals of stem cells, FDA regulatory approval, FDA guidance, stem cells technologies, commercialization of stem cell technologies and more.


Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

July 14-15, 2016

DoubleTree by Hilton Hotel San Francisco Airport, 835 Airport Blvd, Burlingame, CA 94010, USA, SanFrancisco, CA , CA, United States

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools. The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Industries: • Pharmaceuticals • Biotech • Medical Device • Radiological Health • Blood Products • Companion Animals • Food • Cosmetics • Tobacco • Academia Speaker: Angela Bazigos CEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. Location: SanFrancisco, CA Date: July 14th & 15th, 2016 and Time: 9:00 AM to 6:00 PM Venue: DoubleTree by Hilton Hotel San Francisco Airport Address: 835 Airport Blvd, Burlingame, CA 94010, USA Price: Without Stay - Price: $1,495.00 With Stay - Price: $1,895.00 Get fabulous discounts by participating in groups of 2 or more Special Offer, Register for 5 attendees (With Accommodation) Includes Price: $6,633.00 (Flat 30% OFF - You Save $2,842.5 (30%) Quick Contact: NetZealous DBA as GlobalCompliancePanel support@globalcompliancepanel.com Phone: 1-800-447-9407 Fax: 302-288-6884 Registration Link - http://globalcompliancepanel.viewpage.co/Validation-and-21-CFR-11-Compliance


Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

July 14-15, 2016

DoubleTree by Hilton Hotel San Francisco Airport, 835 Airport Blvd, Burlingame, CA 94010, USA, SanFrancisco, CA, CA, United States

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools. The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Industries: • Pharmaceuticals • Biotech • Medical Device • Radiological Health • Blood Products • Companion Animals • Food • Cosmetics • Tobacco • Academia Speaker: Angela Bazigos CEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. Location: SanFrancisco, CA Date: July 14th & 15th, 2016 and Time: 9:00 AM to 6:00 PM Venue: DoubleTree by Hilton Hotel San Francisco Airport Address: 835 Airport Blvd, Burlingame, CA 94010, USA Price: Without Stay - Price: $1,495.00 With Stay - Price: $1,895.00 Get fabulous discounts by participating in groups of 2 or more Special Offer, Register for 5 attendees (With Accommodation) Includes Price: $6,633.00 (Flat 30% OFF - You Save $2,842.5 (30%) Quick Contact: NetZealous DBA as GlobalCompliancePanel support@globalcompliancepanel.com Phone: 1-800-447-9407 Fax: 302-288-6884 Registration Link - http://globalcompliancepanel.viewpage.co/Validation-and-21-CFR-11-Compliance


Seminar on Why is FDA at my Facility, and what do I do During an Inspection

July 18-19, 2016

WILL BE ANNOUNCED SOON, Singapore, Non-U.S., Singapore

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Who will benefit: Industries • FDA regulated Industries o Medical Device o Pharmaceuticals o Clinical • Dietary Supplements o Food o Nutraceutical • Healthcare IT o Technical Services o Validation o Engineering Departments • Top and Middle Management • Quality Assurance/Management • Compliance Management • Manufacturing • Laboratory • Regulatory Affairs • Information Technology • Marketing & Sales • Operations • Research & Development Types of facilities: • Manufacturing facilities • Contract manufacturing facilities • Distributors • Packaging, Labeling • API Suppliers • Laboratories • Importers • Documentation Management Agenda: Day 1 Schedule Lecture 1: How a firm should prepare for an FDA inspection Lecture 2: Ways to train employees in view of the inspection Lecture 3: How to ensure that required documentation is in place Lecture 4: How to interact with the investigator-DO's and DON'T's Lecture 5: What companies should do when the inspection ends Lecture 6: How to reply to 483's and warning letters Lecture 7: Legal implications of non-compliance Lecture 8: Post inspection actions Day 2 Schedule Lecture 1: Why inspections are conducted and by what statutory authority Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Lecture 3: What is subject to FDA purview and what's off-limits Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key Lecture 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus. Location: Singapore Date: July 18th & 19th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 16, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate - With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 16, Regular Price: $2,295.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/During-an-Inspection Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Seminar on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Water Systems for Bio/Pharma, Medical Devices, and Cosmetics Industries

July 18-19, 2016

WILL BE ANNOUNCED SOON , Copenhagen, Non-U.S., Denmark

Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Water Systems for Bio/Pharma, Medical Devices, and Cosmetics Industries" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur. Why should you attend: Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it. Who will benefit: This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are: • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing • Quality Assurance personnel responsible for water system deviation management and change control • Regulatory and Compliance professionals responsible for FDA interactions • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation • Facility Engineers responsible for water system design or renovation • Validation personnel for water system qualification • Change Control personnel involved in water system changes and repairs • Production Managers involved with water system use for manufacturing and cleaning • Laboratory Managers and Supervisors responsible for lab water systems and other water sources Agenda: Day 1 Schedule Lecture 1: What Makes Water Systems Have Microbial Quality Problems • Understand biofilm basics and how it develops • Understand the impact of biofilm on the commonly used purification unit operations • Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development • Understand the how, where, and why of microbial monitoring, action levels, etc. • Debunk a few water system myths • Get answers to your own water system questions Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality • Material and construction limitations • Continuous vs intermittent sanitization • The importance of biofilm removal • How sanitants work (or don't work) • When to sanitize • Troubleshooting sanitization problems Lecture 3: Water System Validation by Logic Instead of Tradition • Why validate a water system? • Basic ground rules for water systems before you validate them • Micro Test Method "validation" • Minimum validation expectations • How to figure out what you should validate • What happens after the honeymoon is over • Is validation ever really over? • Special considerations for lab water systems • Are packaged waters a viable option? Lecture 4: Implementing Changes to a Validated System • Purpose of a Change Control program - a help, not a hindrance • When is a change major vs minor, requiring full vs limited re-qualification? • What about water use during re-qualifications? • FDA validation expectations • Reliance on logic and common sense and the disservice of precedent and paradigms • Additional useful tips Lecture 5: Reducing Water Microbial Excursions & Improving Investigations • What are excursions? • Water system dilemma: process control or quality control (utility or raw material), or both • Intended roles of Alert/Action Levels and Specifications • Investigation, necessary and often fruitless • Excursion responses and impact • Criticality of valves, hoses, & outlet flushing • Diagnosing the source of the problem • Minimizing unnecessary excursion responses through best practices Day 2 Schedule Lecture 6: Understanding and Controlling Endotoxin • Where does endotoxin come from? • What are the properties of endotoxin? • How do you get rid of it? • How do you detect it? • What assay controls are used? • What are the endotoxin specs for water? • How do you control it? Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control • Water harmonization that has occurred • Water Micro TM "Dis-Harmonization" • A little about Biofilm • Biofilm diversity in water systems • Micro TM options and evaluation protocol • The good and bad of Micro harmonization • Where RMMs can fit in • Parting wisdom Lecture 8: Microbial Enumeration Issues with High Purity Water Systems • Microbial Enumeration Issues with High Purity Water Systems • Biofilm enumeration issues (planktonic vs surface) • Traditional cultivative approach issues • Validation of your test method • Alternative TM choices (advantages/disadvantages) • Significance of water isolates • Sampling issues • Establishing Alert/Action Levels and Water Specs and defending them to FDA Lecture 9: Water System Investigation "How-To's" and Example Case Studies • Gathering and assessing existing data and symptoms • Considering user opinions • Investigation approach elements • Recognizing red herrings/false positives • Recognizing possible root causes • Water system contamination case studies • Parting kernels of water system wisdom Lecture 10: What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues • PW, WFI, Pure Steam micro specifications? • Starting water issues • Misunderstood issues clarified • Microbiological test issues clarified • Suggested micro test method • Micro Specifications • Alert and Action Levels and max's • Recent/Upcoming USP water changes • Discrepancies between pharmacopeia's Speaker: Teri C. Soli Principal Consultant, Soli Pharma Solutions Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems. He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University. Location: Copenhagen, Denmark Date: July 18th and 19th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without Stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 16, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate - With Stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 16, Regular Price: $2,295.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/Medical-Devices-and-Cosmetics-Industries Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Dubai Seminar on The A to Z’s of Water Systems for Bio/Pharma, Medical Devices, and Cosmetics Industries

July 18-19, 2016

WILL BE ANNOUNCED SOON, Dubai, DE, United Arab Emirates

Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Water Systems for Bio/Pharma, Medical Devices, and Cosmetics Industries" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur. Why should you attend: Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it. Who will benefit: This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are: • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing • Quality Assurance personnel responsible for water system deviation management and change control • Regulatory and Compliance professionals responsible for FDA interactions • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation • Facility Engineers responsible for water system design or renovation • Validation personnel for water system qualification • Change Control personnel involved in water system changes and repairs • Production Managers involved with water system use for manufacturing and cleaning • Laboratory Managers and Supervisors responsible for lab water systems and other water sources Agenda: Day 1 Schedule Lecture 1: What Makes Water Systems Have Microbial Quality Problems • Understand biofilm basics and how it develops • Understand the impact of biofilm on the commonly used purification unit operations • Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development • Understand the how, where, and why of microbial monitoring, action levels, etc. • Debunk a few water system myths • Get answers to your own water system questions Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality • Material and construction limitations • Continuous vs intermittent sanitization • The importance of biofilm removal • How sanitants work (or don't work) • When to sanitize • Troubleshooting sanitization problems Lecture 3: Water System Validation by Logic Instead of Tradition • Why validate a water system? • Basic ground rules for water systems before you validate them • Micro Test Method "validation" • Minimum validation expectations • How to figure out what you should validate • What happens after the honeymoon is over • Is validation ever really over? • Special considerations for lab water systems • Are packaged waters a viable option? Lecture 4: Implementing Changes to a Validated System • Purpose of a Change Control program - a help, not a hindrance • When is a change major vs minor, requiring full vs limited re-qualification? • What about water use during re-qualifications? • FDA validation expectations • Reliance on logic and common sense and the disservice of precedent and paradigms • Additional useful tips Lecture 5: Reducing Water Microbial Excursions & Improving Investigations • What are excursions? • Water system dilemma: process control or quality control (utility or raw material), or both • Intended roles of Alert/Action Levels and Specifications • Investigation, necessary and often fruitless • Excursion responses and impact • Criticality of valves, hoses, & outlet flushing • Diagnosing the source of the problem • Minimizing unnecessary excursion responses through best practices Day 2 Schedule Lecture 6: Understanding and Controlling Endotoxin • Where does endotoxin come from? • What are the properties of endotoxin? • How do you get rid of it? • How do you detect it? • What assay controls are used? • What are the endotoxin specs for water? • How do you control it? Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control • Water harmonization that has occurred • Water Micro TM "Dis-Harmonization" • A little about Biofilm • Biofilm diversity in water systems • Micro TM options and evaluation protocol • The good and bad of Micro harmonization • Where RMMs can fit in • Parting wisdom Lecture 8: Microbial Enumeration Issues with High Purity Water Systems • Microbial Enumeration Issues with High Purity Water Systems • Biofilm enumeration issues (planktonic vs surface) • Traditional cultivative approach issues • Validation of your test method • Alternative TM choices (advantages/disadvantages) • Significance of water isolates • Sampling issues • Establishing Alert/Action Levels and Water Specs and defending them to FDA Lecture 9: Water System Investigation "How-To's" and Example Case Studies • Gathering and assessing existing data and symptoms • Considering user opinions • Investigation approach elements • Recognizing red herrings/false positives • Recognizing possible root causes • Water system contamination case studies • Parting kernels of water system wisdom Lecture 10: What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues • PW, WFI, Pure Steam micro specifications? • Starting water issues • Misunderstood issues clarified • Microbiological test issues clarified • Suggested micro test method • Micro Specifications • Alert and Action Levels and max's • Recent/Upcoming USP water changes • Discrepancies between pharmacopeia's Speaker: Teri C. Soli Principal Consultant, Soli Pharma Solutions Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems. He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University. Location: Dubai, UAE Date: July 18th and 19th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without Stay) Until June 20, Early Bird Price: $1,695.00 From June 21 to July 16, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate - With Stay) Until June 20, Early Bird Price: $2,095.00 From June 21 to July 16, Regular Price: $2,295.00 Register for 5 attendees (With stay) Includes Price: $7,333.00 You Save: $3,142.5 (30%)* Until June 20, Early Bird Price: $1,0475.00 From June 21 to July 16, Regular Price: $1,0675.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/1U5mScY-Mastering-Biofilm-Control Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


How to Manage Pharma Packaging Complexity

July 19-19, 2016

Onlin, Online, Non-U.S., Canada

In this webinar, the presenter will show how pharmaceutical packaging and labeling complexity occurs, what the consequences are of inaction, and most importantly, what pharmaceutical companies can do to reduce and manage the process.


Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

July 21-22, 2016

Venue to be announced shortly, San Francisco, CA, United States

This seminar will give you complete oversight of CMOs from start to finish. You will learn CMO selection, qualification, quality agreement, CMO operations, CMO records, CMO audit ,project management and more.


Cape Town Seminar on How to Prepare For and Survive During an FDA Inspection

July 21-22, 2016

WILL BE ANNOUNCED SOON, Cape Town, SA , Cape Town, SA , CA, South Africa

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Who will benefit: Industries • FDA regulated Industries o Medical Device o Pharmaceuticals o Clinical • Dietary Supplements o Food o Nutraceutical • Healthcare IT o Technical Services o Validation o Engineering Departments • Top and Middle Management • Quality Assurance/Management • Compliance Management • Manufacturing • Laboratory • Regulatory Affairs • Information Technology • Marketing & Sales • Operations • Research & Development Types of facilities: • Manufacturing facilities • Contract manufacturing facilities • Distributors • Packaging, Labeling • API Suppliers • Laboratories • Importers • Documentation Management Agenda: Day 1 Schedule Lecture 1: How a firm should prepare for an FDA inspection Lecture 2: Ways to train employees in view of the inspection Lecture 3: How to ensure that required documentation is in place Lecture 4: How to interact with the investigator-DO's and DON'T's Lecture 5: What companies should do when the inspection ends Lecture 6: How to reply to 483's and warning letters Lecture 7: Legal implications of non-compliance Lecture 8: Post inspection actions Day 2 Schedule Lecture 1: Why inspections are conducted and by what statutory authority Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Lecture 3: What is subject to FDA purview and what's off-limits Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key Lecture 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Location: Cape Town, SA Date: July 21st and 22nd, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON, Cape Town, SA Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 19, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate - With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 19, Regular Price: $2,295.00 Register for 5 attendees (With stay) Includes Price: $7,333.00 You Save: $3,142.5 (30%)* Until June 20, Early Bird Price: $1,0475.00 From June 21 to July 19, Regular Price: $1,0675.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/1t4ho9i-FDA-at-my-facility Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Seminar on Complaint Handling and Management: From Receipt to Trending

July 25-26, 2016

WILL BE ANNOUNCED SOON , Copenhagen, Denmark , CA, Denmark

Course "Complaint Handling and Management: From Receipt to Trending" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing. Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA. The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Why should you attend: • Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system • Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls • All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints • Provide information about FDA's Medical Device Reporting MDR) regulation and the Voluntary Reporting program called MedWatch • Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities • Latest Amendments to the MDR Regulation to Implement FDAMA Changes • To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required • Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion • Review and discuss pain points,challenges and solutions Areas Covered in the Session: Areas of special concentration will include: • Reporting complaints • Managers • Complaint evaluation and investigation • Data collection and trending • CAPA process for investigating complaints • Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next • Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators • Improve communication and teamwork on complaints across departments and functional areas • Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process • Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints • Understand the History of MDR Regulation • What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA? • Who can submit Voluntary Reports to the FDA? • How Does the FDA Use Medical Device Reports? • What are the exemptions, variances, or alternative forms of adverse event reporting requirements? • Basics of a Recall: Initiation, Classification and Public Warning • Medical Device Recall Reporting • Recall Responsibilities & Requirements • FDA's Role • Introduction to Medical Device Recalls: Industry Responsibilities • Recall Communication and Strategy • Monitoring and Auditing Recall Effectiveness • Recall Termination • Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends Who will benefit: • Regulatory management • QA management • Customer Service personnel • Sales personnel • Consultants • Quality system auditors Agenda: Day 1 Schedule Lecture 1: Complaint Handling: • What are the elements of an effective complaint management system? • How does risk management influence complaint handling decisions? • What are the responsibilities of other departments? • What is the best way to train customer contact employees? • What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events? • What and how do you perform trending? • What are examples of how companies trend and analyze service calls and product complaints? • Understand how and why CAPA is tied in to product complaint investigation • What is an appropriate complaint handling system in a risk-based post-market environment? • How do you audit a complaint handling system? • From your audits, how do you judge that your complaint handling system is effective? • Assignment of responsibility • Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations • Identify designated complaint handling unit • Instructions for documenting complaint information • Process for evaluating complaints • Process for investigating complaints • Identify and process MDR's • How to process customer returns • Records and trend analysis • Complaint closure • Examples of tools currently being used to conduct investigations • How far and in-depth do you go with your investigations • What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations • How to become a "good" investigator and the emphasis on closed-loop investigations • Written Procedures: Designated Complaint Handling Unit, Training and Records • Recent Enforcement Actions Lecture 2: Medical Device Reporting • Introduction to Medical Device Reporting • What are the key terms, definitions and forms? • MDR procedures and processes • What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? • How do you manage international reporting requirements under your complaint handling system? • Consider the relationship between MDRs and Risk Assessments Lecture 3: Exercise and Recap of Day 1 • Exercise on Product Complaints/Complaint Handling • Quiz Day 2 Schedule Lecture 1: Medical Device Reporting • eMDR Electronic Medical Device Reporting • How to Report a Problem • Event Problem Codes and Manufacturer Evaluation Codes • MedWatch: Safety Information and AER Program • Completing Form FDA 3500A • What form should I use to submit reports of individual adverse events and where do I obtain these forms? • Where and how do I submit reports and additional information? • Does the information in my report constitute an admission that the device caused or contributed to the reportable event? • What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me? • Requirements for Individual Adverse Event Reports • User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements Lecture 2: Recalls • What happens in a medical device recall: Firm-initiated recall vs. mandatory recall • What information needs to be reported? • What types of records do companies need to keep? • Prior to notifying FDA, what steps should you have taken? • What are the dos and don'ts when informing FDA of a product problem? • Who should be involved in the decision process? • Who should be responsible for communicating with FDA? • What are the consequences of a recall? • What factors should you consider when determining whether or not to get your product back? • How do you prepare for a post recall inspection? • What customer and other outside communications are necessary? • What documentation should be prepared? • How should the product liability implications of recall communications be handled? • What is an effectiveness check? • Health Hazard Evaluations are conducted by FDA • How should you write your recall correspondence? • How do you determine that your recall is completed and what do you do to close your recall internally and with FDA? • Create and use a recall operational • Understand what is required for the recall strategy as expected by FDA • Depth of recall and using a viable, sustainable and effective strategy • Understand why the documentation and paper trail are so critical and termination of a recall • Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming Lecture 3: Exercise and Recap of Day 2 • Exercise - MDR and Recall • Quiz Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. Location: Copenhagen, Denmark Date: July 25th and 26th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 23, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate – With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 23, Regular Price: $2,295.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900551SEMINAR Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Cape Town Seminar on Complaint Handling and Management

July 25-26, 2016

WILL BE ANNOUNCED SOON, Cape Town, SA, Non-U.S., South Africa

Course "Complaint Handling and Management: From Receipt to Trending" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing. Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA. The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Why should you attend: • Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system • Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls • All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints • Provide information about FDA's Medical Device Reporting MDR) regulation and the Voluntary Reporting program called MedWatch • Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities • Latest Amendments to the MDR Regulation to Implement FDAMA Changes • To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required • Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion • Review and discuss pain points,challenges and solutions Areas Covered in the Session: Areas of special concentration will include: • Reporting complaints • Managers • Complaint evaluation and investigation • Data collection and trending • CAPA process for investigating complaints • Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next • Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators • Improve communication and teamwork on complaints across departments and functional areas • Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process • Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints • Understand the History of MDR Regulation • What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA? • Who can submit Voluntary Reports to the FDA? • How Does the FDA Use Medical Device Reports? • What are the exemptions, variances, or alternative forms of adverse event reporting requirements? • Basics of a Recall: Initiation, Classification and Public Warning • Medical Device Recall Reporting • Recall Responsibilities & Requirements • FDA's Role • Introduction to Medical Device Recalls: Industry Responsibilities • Recall Communication and Strategy • Monitoring and Auditing Recall Effectiveness • Recall Termination • Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends Who will benefit: • Regulatory management • QA management • Customer Service personnel • Sales personnel • Consultants • Quality system auditors Agenda: Day 1 Schedule Lecture 1: Complaint Handling: • What are the elements of an effective complaint management system? • How does risk management influence complaint handling decisions? • What are the responsibilities of other departments? • What is the best way to train customer contact employees? • What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events? • What and how do you perform trending? • What are examples of how companies trend and analyze service calls and product complaints? • Understand how and why CAPA is tied in to product complaint investigation • What is an appropriate complaint handling system in a risk-based post-market environment? • How do you audit a complaint handling system? • From your audits, how do you judge that your complaint handling system is effective? • Assignment of responsibility • Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations • Identify designated complaint handling unit • Instructions for documenting complaint information • Process for evaluating complaints • Process for investigating complaints • Identify and process MDR's • How to process customer returns • Records and trend analysis • Complaint closure • Examples of tools currently being used to conduct investigations • How far and in-depth do you go with your investigations • What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations • How to become a "good" investigator and the emphasis on closed-loop investigations • Written Procedures: Designated Complaint Handling Unit, Training and Records • Recent Enforcement Actions Lecture 2: Medical Device Reporting • Introduction to Medical Device Reporting • What are the key terms, definitions and forms? • MDR procedures and processes • What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? • How do you manage international reporting requirements under your complaint handling system? • Consider the relationship between MDRs and Risk Assessments Lecture 3: Exercise and Recap of Day 1 • Exercise on Product Complaints/Complaint Handling • Quiz Day 2 Schedule Lecture 1: Medical Device Reporting • eMDR Electronic Medical Device Reporting • How to Report a Problem • Event Problem Codes and Manufacturer Evaluation Codes • MedWatch: Safety Information and AER Program • Completing Form FDA 3500A • What form should I use to submit reports of individual adverse events and where do I obtain these forms? • Where and how do I submit reports and additional information? • Does the information in my report constitute an admission that the device caused or contributed to the reportable event? • What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me? • Requirements for Individual Adverse Event Reports • User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements Lecture 2: Recalls • What happens in a medical device recall: Firm-initiated recall vs. mandatory recall • What information needs to be reported? • What types of records do companies need to keep? • Prior to notifying FDA, what steps should you have taken? • What are the dos and don'ts when informing FDA of a product problem? • Who should be involved in the decision process? • Who should be responsible for communicating with FDA? • What are the consequences of a recall? • What factors should you consider when determining whether or not to get your product back? • How do you prepare for a post recall inspection? • What customer and other outside communications are necessary? • What documentation should be prepared? • How should the product liability implications of recall communications be handled? • What is an effectiveness check? • Health Hazard Evaluations are conducted by FDA • How should you write your recall correspondence? • How do you determine that your recall is completed and what do you do to close your recall internally and with FDA? • Create and use a recall operational • Understand what is required for the recall strategy as expected by FDA • Depth of recall and using a viable, sustainable and effective strategy • Understand why the documentation and paper trail are so critical and termination of a recall • Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming Lecture 3: Exercise and Recap of Day 2 • Exercise - MDR and Recall • Quiz Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. Location: Cape Town, SA Date: July 25th and 26th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 23, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate – With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 23, Regular Price: $2,295.00 Register for 5 attendees (With stay) Includes Price: $7,333.00 You Save: $3,142.5 (30%)* Until June 20, Early Bird Price: $1, 0475.00 from June 21 to July 23, Regular Price: $1, 0675.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/1TX9GKm-complaint-handling Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Advanced API 2016

July 25-27, 2016

The Westin, Mumbai, Mumbai, Non-U.S., India

The 3rd Annual Advanced API Convention will be held in Mumbai between 25 – 27 July 2016. Intended as the foremost event for the API industry in India, the Advanced API Convention 2016 is an exciting event bringing the scientists of the world, Industry experts and key stakeholders under one platform. The Indian API market stands third in the world. At the same time, it relies heavily on China. This is a serious matter of concern which needs to be addressed to reduce dependency on China. CPhI always strives to voice out the concerns of Pharma professionals, and this year again we are delighted to bring you the 3rd Annual Advanced API Convention with an idea to encourage production of quality API’s, tackling problems right from R&D to Manufacturing phase.


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August 2016

6th Digital Marketing for Medical Devices

August 1-3, 2016

Hyatt Regency Minneapolis, Minneapolis, MN, United States

Now in our sixth year, the Digital Marketing for Medical Devices event has become the place for device marketers to inspire and learn from one another. Return to the office with a strategy to provide your customers with engaging, relevant, valuable information via the channels they prefer. Join more than 150 device marketers at the leading marketing event for the medical device industry, where you’ll gain an in-depth understanding of how to develop an effective digital marketing campaign to increase your product and brand’s digital presence. Much like the industry is continuously changing, our programs have evolved to ensure you walk away from our conferences with new trends on your radar and a strategic plan to implement tactics that will improve your marketing.


Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

August 2-3, 2016

Venue to be announced shortly, San Francisco, CA, United States

Learn FDA regulatory requirements for manufacturing, labeling and marketing of cosmeceutical and homeopathic OTCs not covered by approved New Drug Applications. Learn OTC monographs and get tips to minimize the regulatory risk of Warning Letters and other FDA enforcement actions.


11th Annual Manufacturing Execution Systems(MES) 2016

August 10-11, 2016

Doubletree Center City, Philadelphia, PA, United States

MES 2016, the life science industry’s most in-depth manufacturing systems-focused event, is packed with breakthrough content and next-generation strategies for achieving the highest ROI on your MES activities. Gain insight on innovative applications and processes to master advanced IT-based solutions in highly regulated environments. Collaborate on prevailing industry approaches to ensure manufacturing intelligence and excellence by successfully deploying, integrating, maintaining and utilizing data from MES.


Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

August 18-19, 2016

Venue to be announced shortly, Burlingame, CA, United States

Attend this workshop to learn goals and objectives of Process Validation for pharma industry.


Statistical Analysis for Process and Product Development

August 25-26, 2016

Venue to be announced shortly, Tampa, FL, United States

Learn to apply Hypothesis Testing methods, use of confidence intervals, sample studies and Design of Experiments (DOE). You will learn Statistical Analysis for Process and Product Development through graphical analysis, experimental design, factorial design, significant effects and mathematical methods.


76th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2016

August 28 - September 1, 2016

Hilton Hotel Buenos Aires, Buenos Aires, Non-U.S., Argentina

Each year the international FIP Congress is organized in a different city in the world together with one of FIP's Member Associations. Around 3000 Pharmacists and Pharmaceutical scientists from over 100 countries come together to network, learn, discuss and take part in an excellent social program. Topic A: Social determinants of health Topic B: Novel tools for prevention and treatment Topic C: Diagnostics and adherence – putting progress into collaborative practice. Topic D: Sustainable and affordable global health Topic E: Miscellaneous For sponsorship and exhibition opportunities, please get in touch.


7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 29-31, 2016

Hilton Atlanta Airport, Atlanta, GA, USA

BABE 2016 Conference invites all the participants across the globe to attend the " 7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit.”  It is a scientific platform to meet fellow key decision makers all-around the Academic Institutions, Healthcare Institutes, Pharmaceutical, Biotech, CROs supply chain, Logistics practitioners making the congress a perfect platform to share experience, foster collaborations through the research talks & presentations to put forward many thought provoking strategies. It's a perfect stage to brainstorm, discover new ideas, search for new skills and a platform to show your capabilities and discoveries to the world. BABE 2016 will be one of the outstanding Bioavailability and Bioequivalence Conferences.


3D Tissue Models 2016

August 29-31, 2016

Hotel Karlan, San Diego, CA, United States

3D Tissue Models 2016 is designed to tackle critical questions about the true utility and limitations of 3D tissue models in pharmaceutical development. Hosting top decision makers from industry and academia, this unique summit will provide you with a collaborative platform to share and tackle your key drug development, biological and commercial challenges. The case-study driven agenda and data centric approach will reveal the practical applications of these technologies, going beyond the science of tissue engineering. Discover how leading pharmaceutical companies deploy organ-on-a-chip, organoid and other stem cell derived tissue technologies in drug discovery, toxicology, systems pharmacology and DMPK applications - to expedite discovery and translation to clinical research.


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September 2016

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

September 8-9, 2016

Venue to be announced shortly, Barcelona, Non-U.S., Spain

Raw Material Requirements in a cGMP Environment | Health Canada, USP, EP


World Anti-Microbial Resistance Congress USA 2016

September 8-9, 2016

Washington Court Hotel, Washington, D.C., DC, United States

The World AntiMicrobial Resistance Congress gathers key stakeholders from government, funding agencies, pharma, academia, hospitals, and payers to discuss this urgent need for new antibiotics. President Obama has outlined his 5-year action plan to fight AMR and is seeking to double the AMR funding to USD 1.2B, but the bigger challenge is how to deliver these actions. This 2-day conference presents solutions through key notes, case study presentations, expert opinion, roundtable discussions and invites key influencers such as BARDA, NIH, FDA, grant agencies, pharma, hospitals, and academia, in the AMR discussion. We understand the importance of focused learning and enhanced networking so we have put together a conference that brings together innovative formats with 5+ hours of assisted networking during 40-minute coffee breaks and 1 ½ hour lunch breaks. We end Day One with a Cocktail Hour so that you can network with your peers in a more relaxed setting! If you are developing an antibiotic or provide solutions to develop antibiotics, prevent spread of AMR, monitor it in real time or have alternative ways to fund antibiotic R and D, don’t miss out. Be sure to join us at the World AMR Congress this September.


Process WATER Technologies

September 11-14, 2016

Texas A&M University, College Station, TX, United States

The Separation Sciences Program in the Food Protein Research and Development Center at Texas A&M University presents a “hands-on” WATER Short Course covering pretreatment equipment, processing, systems, field testing, case studies, and post-treatment technologies to food, dairy, & beverage industries. Now is the time to see how it works from the leading water and equipment professionals.


2016 PDA/FDA Joint Regulatory Conference

September 12-13, 2016

Renaissance, DC Hotel, Washington, DC, United States

For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.


2016 PDA Data Integrity Workshop

September 14-15, 2016

Renaissance Washington, DC Hotel, Washington, DC, United States

The 2016 PDA Data Integrity Workshop, offered several times in global locations, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.


Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology

September 15-16, 2016

Venue to be announced shortly, Philadelphia, PA, United States

Learn essentials of USP microbiology - reading between the lines of the USP general and information microbiology chapters. Explore Form FDA 483s and Warning Letters for microbiological applications.


Investigator Site Files Summit

September 19-20, 2016

Wyndham Boston Beacon Hill, 5 Blossom St., Boston, MA, United States

Over the course of two days, industry leaders at the Investigator Site Files Summit will take part in case studies, a panel and engaging sessions developed to ensure conference attendees walk away with a better understanding of how proper document management of the ISF can increase a clinical trial’s quality while monitoring the progress of a trial. In addition to our main program, our pre-conference workshop teaches attendees how to build an ISF management plan that can be used by the sponsor as a template for all sites in a study or by the investigative site for all studies they are conducting. Join us to enrich the quality of your ISF and protect your organization from the risks incomplete, outdated or inaccurate files can cause.


Advanced Pharma Analytics USA 2016

September 20-22, 2016

Hyatt Morristown at Headquarters Plaza, Morristown, NJ, United States

As the pharmaceutical industry strives to extract meaningful insight, value and outcomes from their data analytics, pharma and biotech are experiencing a significant movement towards real-world evidence to power the advanced decision-making to optimize patient-centric approaches. This evolution has led to a fresh focus for the 4th Annual Advanced Pharma Analytics Summit (formerly know as Big Data in Pharma). Join the industry to learn about the successful application of advanced data analytics tools, including big data and predictive analytics, to progress products in the late stages of their life cycle. This year’s summit will also highlight the significant opportunities present within real-world evidence to compliment clinical trial data and to drive forward regulatory approval and post-approval evidence. The 4th APA Summit 2016 will showcase the latest case studies from the likes of Genentech, Pfizer, Novartis and the FDA that demonstrate value and tangible ROI derived from effective data sourcing, standardization, integration, infrastructure, real-world evidence and advanced analytics. Discover the right technology, tools and customized analytics capabilities you need to make improved data-driven decisions to optimize health economics, market access, pricing and reimbursement strategies. Join the Advanced Pharma Analytics community to fully realize and extract the right value and insight you need from your data and real-world evidence.


Sensors Midwest

September 27-28, 2016

Donald E. Stephens Convention Center, Rosemont, IL, United States

We’re back! Co-located with SMTA International, Sensors will be bringing the best technical innovation and thought leadership in the world of sensors back to the Midwest. Sensors Midwest will focus on hot and trending sensor technologies including Embedded Systems, Printed/Flexible/Wearable, IoT, MEMS, Robotics, Wireless, and much more!

The 2-day event will feature education, networking, and a packed Expo Floor with an anticipated 65+ exhibitors showcasing their latest sensing technology and products. The Education Program will feature different tracks that will explore cutting-edge trends & applications, case studies, and demos from the industry’s leaders and experts. With Education Theaters directly on the Expo Floor, networking opportunities & parties, and direct access to both SMTAI and Sensors Midwest events, attendees are guaranteed to explore new technologies and find solutions to their current sensing challenges.

Join us this September 27-28 in Rosemont, Illinois as we celebrate our return to the Midwest!

Visit www.sensorsmidwest.com to register today and for the latest information on the 2016 event. Register soon - Expo Passes are FREE for a limited time!


PSA: The Pharmaceutical Strategy Conference

September 28-30, 2016

Marriott Marquis Times Square, New York, NY, United States

As blockbuster acquisitions, asset swaps, and divestitures continue into 2016, we examine the key scientific, development, commercial, and business model issues facing an industry tasked with proving the value of its therapies like never before. Hear from thought leaders across the spectrum of biotech, pharmaceutical, and payer perspectives as the drug industry embraces new strategies for long-term success.


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October 2016

BioProcess International Conference and Exposition

October 4-7, 2016

Boston Convention and Exhibition Center, Boston, MA, United States

BPI offers the best of both worlds - unsurpassed networking and learning offered by a large, multi-track conference and exhibition combined with informal opportunities to connect with like-minded scientific peers or customers in small group problem-solving sessions and focused discussions.


Cell and Gene Therapy BioProcessing and Commercialization

October 5-7, 2016

Boston Convention and Exhibition Center, Boston, MA, United States

Cell and Gene Therapy BioProcessing and Commercialization meeting delivers the focused science and business content designed specifically for the cell therapy and regenerative medicine fields, while providing a pivotal gathering place for connecting industry, funding sources, government and academia.


Partnerships in Clinical Trials USA 2016

October 5-7, 2016

PCT Loft at the Boston Convention and Exhibition Center, 415 Summer Street, 02210, Boston, MA, United States

Push Novel Drugs to Market through Clinical Trials Innovation, Technology and Strategic Relationships. Running for the 25th year, Dive into outsourcing, data analytics, customer service, and innovation from outside luminaries in industries thrust into dynamic and digital transformation or fresh insights and best practices to apply to your trials. Following last year's successful spotlight session on Ebola, this year's spotlight is on Zika. RandD Challenges in Finding a Cure: Lessons Learned from Running a Clinical Trial for the Zika will review how best to tackle this growing global epidemic and why rethinking traditional clinical trial processes to fast track to a cure is the leading approach.


ComplianceOnline Pharma Summit 2016 – Risk Control and Compliance

October 6-7, 2016

Venue to be announced shortly, Philadelphia, PA, United States

The ComplianceOnline Pharma Summit 2016 - Risk control & Compliance aims to bring together FDA, Experts, Leaders and Veterans to discuss the most important challenges of Biotech, Pharma industry.


Patient-Centered Clinical Trials

October 10-11, 2016

Sonesta Hotel, Philadelphia, PA, United States

In its 3rd year eyeforpharma Patient-Centered Clinical Trials 2016 (10-11th October, Philadelphia) is the only platform to bring together a truly patient-centered dialogue between pharma and patients. This is your opportunity to join 200 of your peers for 2 days of expert presentations, heated panel discussion, interactive exhibition and exclusive networking. Hear how Bayer, Tesaro Novartis and CTTI are all making steps towards patient-centricity in clinical trials. Join all key stakeholders in clinical trials, including the patients themselves. This year’s entire agenda has been designed and shaped with the help of thousands of patient voices through a global survey and multiple in-depth consultations. This is your one stop shop to ensure your trials are optimised to be truly patient-centric. Don’t miss out, reserve your place today


eyeforpharma Sydney 2016

October 11-12, 2016

ParkRoyal Darling Harbour, Sydney, Non-U.S., Australia

eyeforpharma Sydney 2016 In its 6th year eyeforpharma Sydney 2016 (11-12th October, Sydney) brings together the most innovative commercial minds from throughout the pharma industry. This is your opportunity to join 200 of your peers for 2 days of expert presentations, heated panel discussions, interactive exhibitions and exclusive networking. Join the most innovative speakers from across the Australia and AP region, including case studies from Bayer, Celgene, Pfizer, Novartis, MSD, Roche, as well as keynote presentations from the Dept. of Health and the TGA, and our out of industry specialists. Whether it’s maximising the profitability of your portfolio, delivering higher ROI from your marketing efforts or trying to build a more holistic customer experience this is your one stop shop to ensure your commercial strategy is perfected for 2017 and beyond. Don’t miss out, reserve your place today - http://goo.gl/o1cZqz


9th Annual Clinical Forum and Exhibition

October 13-14, 2016

Hilton Dusseldorf Hotel, Düsseldorf, Non-U.S., Germany

Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena. Particularly 2016 will bring important changes in the European Regulatory framework once the ICH E6 Addendum kicks in. At that time ‘Quality’ is no longer the outcome of well-designed processes, but it should be an explicit and very well-considered strategy in the way we design our processes and studies. Risk-Based Monitoring will be codified in Good Clinical Practice, and many organizations will have to revisit their Standard Operations Procedures, processes and study-related documents. And obviously, this will have an impact on the roles of professionals working in clinical development.


Patients Summit Europe

October 17-18, 2016

Park Plaza Victoria London, London, Non-U.S., United Kingdom

Patient Summit Europe 2016 Now in its 13th year, the Patient Summit Europe (17th-18th October 2016, London) is the definitive meeting point for healthcare professionals who all share the same ambition – improving patient-centred care. With expert presentations from big pharma, patient advocacy groups, KOLs and real patients, this Summit brings together all key stakeholders under one roof. Over 2 days you will have the opportunity to learn, share best practise, and network with Europe’s most innovative minds in healthcare. Hear about the industry’s most ground-breaking case studies, recognise how you can take patient-centricity to the next level in your company, and prove that this business model is win-win for everyone. This is your opportunity to understand how to put your organisation on the fast track to truly productive and profitable patient-centricity. Don’t miss out, reserve your place today - http://goo.gl/mZXSGU


2016 PDA Universe of Pre-filled Syringes and Injection Devices

October 17-18, 2016

Hyatt Regency Huntington Beach Resort and Spa , Huntington Beach , CA, United States

At the 2016 PDA Universe of Pre-filled Syringes and Injection Devices, industry and regulatory experts will share their experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing or marketing of pre-filled syringes and injection devices.


22nd Annual Validation Week

October 18-20, 2016

Coronado Island Marriott, San Diego, CA, United States

IVT’s Validation Week celebrates its 22nd Anniversary this year! Industry’s flagship event once again provides you the most up-to-date and comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide.


2016 PDA Drug Delivery Combination Products Workshop

October 19-19, 2016

Hyatt Regency Huntington Beach Resort and Spa , Huntington Beach, CA, United States

At the 2016 PDA Drug Delivery Combination Products Workshop, experts from across the drug-delivery device development spectrum will discuss the challenges they have had or are currently facing and how they’ve successfully addressed them. Interact with the participants in panel discussions on issues such as human factors, clinical studies, risk management and new challenges of design transfer, change control and FDA inspection compliance expectations.


5th European Trial Master File Summit

October 20-21, 2016

Radisson Blu Portman Hotel London, London, Non-U.S., United Kingdom

Over the last four years, ExL's Trial Master File Series has been the industry's go-to set of conferences for education and networking related to paper and electronic TMFs. The 5th European Trial Master File Summit will delve into many key topics relevant to specialists in this field. Join 100+ TMF professionals as our expert faculty explores nuances of Trial Master Files, including: eTMF processes, quality and metrics, the impact of a TMF in an MandA environment, content integration, TMF maturity, the business case for an eTMF, collaboration with a CRO, TMF completeness, quality and delivery, eTMFs and the CRO-sponsor relationship, TMF completeness and compliance, an eISF's impact on how sites manage TMFs, V3 of the TMF reference model and much more!


ISPE Europe Conference on BIOTECHNOLOGY

October 24-25, 2016

Industriepark Höchst, Frankfurt, Non-U.S., Germany

Biopharmaceutical products are facing a prosperous future. The 2016 ISPE Europe Conference on Biotechnology, Reinventing Commercial Bio Manufacturing, collects novel tools in knowledge management, process science, and technological advancements to tackle these future challenges, which include: Increased competition by additional approvals of biosimilars Enhanced regulatory requirements for traceability along the process development life cycle Urgency for new technologies Solutions for process optimisation Transparency in process development We are proud to have assembled an innovative programme of highly respected speakers from regulatory, manufacturers, service providers, and academia to present best practices and case studies. Why attend? Learn about GMP challenges and opportunities for biomanufacturing Understand the implications of the new regulations, like Annex 1 and 2, for biopharmaceuticals Discuss and explore success factors of knowledge management and technology transfer in Biopharma See first-hand innovative solutions in process development Four Plant Visits options available in Industriepark Höchst at Sanofi: Multi-Insulin Plant Lantus (Insulin) Plant Cell Culture Pilot Plant for Development Höchst Industry Park Tour (History and Current Operation)


11th Annual PDA Global Conference on Pharmaceutical Microbiology

October 24-26, 2016

Hyatt Regency Crystal City , Arlington, VA, United States

At the 11th Annual PDA Global Conference on Pharmaceutical Microbiology, top industry, academic and regulatory professionals will share the latest advances and best practices for the development of standards and integration of innovative technologies that address product quality and infection control in pharmaceutical microbiology.


Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision

October 26-27, 2016

Hyatt Regency Crystal City, Arlington, VA, United States

The Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision Workshop provides a forum for industry and regulatory professionals to discuss science- and risk-based approaches that support modern aseptic processing and control strategies and will shape new regulations. It will explore the critical topics within the scope of the new revision of the EU GMP Annex 1, which will impact the future of global manufacturing of sterile medicines. Experts will discuss the most frequently raised questions in the interpretation of applicable regulations for aseptic processing and will provide recommendations for best practices for sterile product manufacturing.


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November 2016

2016 PDA Outsourcing/CMO Conference

November 3-4, 2016

Renaissance Washington, DC Hotel , Washington, DC, United States

The 2016 PDA Outsourcing/CMO Conference will showcase relevant case studies that demonstrate the importance of shared goals and partnership to bring important therapies to ever wider markets. Hear from industry leaders about their experiences in driving collaborative best practices for development and commercial execution of outsourcing partnerships.


5th Annual Cell Culture & Bioprocessing Congress 2016

November 3-4, 2016

The Radisson Blu Hotel, London , London, Non-U.S., United Kingdom

Oxford Global are proud to present the 5th Annual Cell Culture & Bioprocessing Congress, taking place on the 3-4 November 2016 at the Radisson Blu Portman Hotel in London. This Congress is an executive platform for over 170 experts to network, exchange ideas, and discuss the latest innovations in the field. Delegates come from a variety of areas, including cell line development, cell line engineering, up and downstream operations, biotechnology, process development, biologics production and more. Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions 50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production 4 interactive streams: - Cell Line Development: Stem Cells, Genome-Editing, CRISPR & NGS - Process Development - Cell Line Development: Mammalian & Bacterial Expression Systems - Biological Production 14 pre-scheduled one to one meetings, exhibition and informal networking opportunities. This Congress is an executive platform for over 170 experts to network, exchange ideas, and discuss the latest innovations in the field. Delegates come from a variety of areas, including cell line development, cell line engineering, up and downstream operations, biotechnology, process development, biologics production and more. On Day One, the conference will address stem cell development, gene-editing, cell genome NGS sequencing and CRISPR technology. Our expert speakers will discuss technologies for precise genome editing as well as the potential uses gene editing could have in future, how to ensure quality of raw materials in stem cell culture, and 3D cell culture technologies. Key issues to be covered in our Process Development stream include novel single use technologies, analytics development and the processing of Bispecific antibodies. Day two of the event will see our leading industry and academic speakers present subjects such as the optimisation of cell lines, contamination issues in manufacture, efficient technology transfer, strategies in the use of Quality by Design, and the future of continuous processing. Other key topics that delegates will have the opportunity to hear about include first hand experiences from speakers of biosimilar cell line development, and innovation in the early development of bispecific antibodies. Our cell line development stream will have a focus on innovation in the use of both mammalian and bacterial expression systems.


2016 PDA Data Integrity Workshop

November 8-9, 2016

Titanic Chaussee Berlin, Berlin, Non-U.S., Germany

The 2016 PDA Data Integrity Workshop, offered several times in global locations, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.


4th European Biosimilars Conference

November 9-10, 2016

Hotel Pullman Brussels Midi, Brussels, Non-U.S., Belgium

Biosimilar medicines' developments are maintaining their momentum and the 2016 Biosimilars Conference programme delves into strategic discussions regarding: Market and regulatory developments in the EU and globally, enlightened by the perspective of healthcare professionals' and patients' experiences Pharmacovigilance and clinical practice - what can be learned from the emerging data? The impact of biosimilar medicines on the competitive landscape of biological products, in light of 10 years of market existence As the 4th conference of its kind, the 2016 programme gives a complete 360-degree overview of biosimilar medicines. Participants will leave the conference with a wealth of new information and an expanded network of contacts. Featured topics Current regulatory status of biosimilar medicines in the EU and beyond Biological medicines in practice - experiences and views of patients, pharmacists, nurses, physicians and hospital managers/ payers (procurers) Key learnings from multi-stakeholder dialogue platforms on patients and healthcare professionals' information needs The balance of risk and benefits for biosimilars – where it stands after a decade of biosimilar use Interchangeability and switching of biosimilars Clinical experience and real world evidence for biosimilar medicines: what is the state of play in terms of clinical and economic value proposals What you will learn Deal with regulatory requirements, scientific and operational challenges Exchange experiences and discuss hot topics with experts Update the participant on the current knowledge including regulatory and scientific thinking Discuss the necessary conditions for optimal use Who should attend? Regulatory affairs professionals Healthcare professionals Patient advocates Regulators Decision makers


2nd Annual Genome Editing Congress 2016

November 10-11, 2016

Novotel West London, London, Non-U.S., United Kingdom

Oxford Global Conferences are proud to announce the 2nd Annual Genome Editing Congress, taking place on 10-11 November 2016 at the Novotel London West in London, UK. This highly anticipated event provides a unique opportunity for over 450 senior level experts to engage in scientific discussions about the current research results and latest advancements that help the industry going forward. The genome editing market represents a rapidly evolving area of pharmaceutical research since the discovery of the CRISPR/Cas systems that have revolutionised biological research. Significant advancements have been made in the fields of improving genome editing tools & technologies, gene delivery systems and utilising genome editing for therapeutic applications. Genomics research is experiencing an increased funding and thanks to the technological advancements the genome editing market is expected to grow rapidly. Experts have also highlighted that the global market for genome editing is expected to reach over $2.0 billion by 2020. On day one our esteemed speakers will focus on topic areas covering genome editing techniques. Presentations will focus on the latest developments and novel methods for genome editing and engineering as well as advancements in gene editing systems. Genome editing using CRISPR, TALEN & ZFN systems and utilising genome editing in drug discovery and development will also be covered. On day two delegates will have the unique chance to hear presentations on the therapeutic applications of genome editing. Our highly distinguished speakers will deliver case studies from cardiovascular diseases, diabetes, genetic disorders and gene therapy. Key opinion leaders will also address updates in novel genome engineering methods and improving genome targeting precision.


Life Sciences Ingredients

November 10-12, 2016

Istanbul Expo Center, Istanbul, Non-U.S., Turkey

Pharmaceuticals, Food, Cosmetics, Personal and Home Care Ingredients, Raw Materials and Technologies Exhibition: 'Life Sciences Ingredients 2016' “Life Sciences” has become one of the most important industries as it comprises the fields of science that involve everything about humans and life. With its fast growing economy, Turkey and Istanbul has been an attraction center for many international companies who operate in Pharmaceuticals, Food, Cosmetics, Personal and Home Care Ingredients Industries and seeking opportunities to penetrate in Turkey and surrounding markets and supply commercial goods by participating in successful exhibitions. “International Chemical Industry Group Exhibition” Chem Show Eurasia which is a globally renowned and followed exhibition will befeaturing “Life Science Ingredients Show” in 2016. Life Sciences Ingredients 2016, which comprises all components of life, will be held concurrently with Chem Show Eurasia which is the largest and most comprehensive meeting point of the Chemical Industry in Turkey and Eurasia, by gathering the companies operating in the fields of Pharmaceuticals, Food, Cosmetics, Personal and Home Care Ingredients, Raw Materials and Technologies between 10-12 November 2016.


World Precision Medicine Congress USA 2016

November 14-15, 2016

Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue NW, Washington, DC, United States

Precision medicine has the potential to cure diseases previously thought incurable. It has the potential to enhance the quality of life for millions of patients around the world who traditional medications simply aren’t working for. It has the potential to eliminate side-effects as each drug is tailored to a specific subset of individuals. Even President Obama showcased his belief in the potential when he announced the Precision Medicine Initiative (PMI) through the NIH. The question is, how do we get there? Answering this is why we decided to develop the World Precision Medicine Congress USA in Washington, D.C. for 2016. This event is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there. Both the scientific and the business challenges will be represented.


World Biosimilar Congress 2016

November 14-15, 2016

Congress Center Basel, Messeplatz 21, 4058, Basel, Non-U.S., Switzerland

In 2015, we saw the crescendo of the Amgen versus Sandoz case after many months of appeals. Along with that legal case, many more are still ongoing in the biosimilar sector. This year also provided a milestone in the ongoing discussions and debates on naming conventions with both the US FDA and WHO providing their individual guidance on such issues.


World Immunotherapy Congress 2016

November 14-16, 2016

Congress Center Basel, Basel, Non-U.S., Switzerland

Immunotherapy currently offers the brightest hope for cancer treatment. New developments with checkpoint inhibitors and co-stimulatory targets have enabled some stunning breakthroughs and high optimism for the sector. Recently, there have been some incredibly exciting new therapies in areas such as CAR-T and Oncolytic Viral Immunotherapy. Our vision is to bring together the full community and provide a single meeting point for the whole value chain. It is where science meets business to make immunotherapy the cornerstone of the fight against cancer. The event is new, though the ideas and relationships are not. The event comes out of our discussions with leading clinicians, pharmaceutical companies, biotechs and research institutes held every year at the successful European Antibody Congress, now in its twelfth successful year.


Biosimilars North America

November 16-17, 2016

Renaissance Woodbridge Hotel, Iselin, NJ, United States

Following the first approval of biosimilars in the US, FDA has received even more applications and the industry is expecting 2 more products receiving the green light this year. Nonetheless, the recent Remicade case between Celltrion and JandJ has also casted doubts amongst market participants. The 3rd annual Biosimilars USA conference will return in November to discuss the following topics in such evolving market landscape: Examine the latest biosimilar applications and cases Evaluate the global biosimilars market and assist delegates to define the optimal penetration strategy Reveal latest regulatory and legal updates to ensure smooth approval and licensing process Debate how to de-risk and develop a holistic value chain for biosimilars commercialization Define post-launch and marketing plan: What are the distribution channels? Portfolio and branding strategy of biosimilars: How should we build a sustainable business model? Assess technological breakthroughs to speed up characterization and drug development programs Understand rationale behind pricing and discount - engage with your payers Chairman: Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc. Elite Speaker Panel 2016: Edric Engert, Senior Vice President, Biosimilars, Teva Pharmaceuticals Gustavo Grampp, Ph.D., Director RandD Policy - Biosimilars, Amgen Inc. Hillel Cohen, Executive Director, Scientifi c Affairs, Sandoz Andrew Simpson, Scientifi c Director, Orygen Biotechnologia S/A Dr. Jianguo Yang, CEO, Abpro-China; Vice President, Abpro-US Daniel Alvarez, Senior Director, Asset Lead, Global Established Pharma, Pfi zer Inc. PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS A: Leveraging Successful Patient Recruitment and Retention Strategies in Biosimilars Research (UBC - An Express Scripts Company) B: Biosimilars: Considerations for Optimizing Access and Price (MKTX Market Access Solutions, LLC)


RPM Expo 2016

November 17-17, 2016

DoubleTree Hotel, Somerset, NJ, United States

RPM Expo is a marketplace for manufacturing engineers, managers, and front line operators to learn about emerging solutions to the complexities of pharmaceutical manufacturing: automation, biologics, small molecules, generics, biosimilars, process engineering, single use, continuous process, regulatory and supply chain concerns.


Mena Pharmaceutical Manufacturing Congress

November 29 - December 1, 2016

Le Meridien , Jeddah, Non-U.S., Saudi Arabia

MENA Pharmaceutical Manufacturing Congress will set a unique platform by gathering the pioneers from the local and international pharmaceutical companies; CEOs, plant managers, production managers, supply chain managers, quality assurance managers, regulators affairs, and managers. In addition to the leading technology providers who will showcase the latest technologies in pharmaceutical manufacturing. The congress will include case studies, presentations, interactive panel discussions focusing on the obstacles fronting the pharmaceutical industry, the integration between the different concerned entities, and the future of the industry in the region; as well as an exhibition featuring the latest machineries used during the different pharmaceutical manufacturing stages, raw materials suppliers, and more.


Chemspec South East Asia 2016

November 30 - December 1, 2016

Queen Sirikit National Convention Center, Bangkok, Non-U.S., Thailand

Chemspec South East Asia 2016 will be held in Bangkok, Thailand, from 30 November – 1 December 2016. The show profiles also covered agrochemical, pharmaceutical, cosmetics, petrochemical, food ingredients. The Chemspec South East Asia - Thailand exhibition will provide a platform for the industry across the ASEAN region and beyond, to meet, trade, discuss and develop performance chemical supplies for the region. One of the strengths of Chemspec exhibitions is to enable suppliers to arrange meetings with key buyers in a structured, confidential and professional environment. This will be the focus of the South East Asia edition in 2016.


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December 2016

Water Purification Systems for Regulated Industries - Design, Chemistry and Validation

December 5-6, 2016

The Desmond Hotel and Conference Center, Malvern, PA, United States

The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications. The course is designed to provide the attendee with a practical understanding of the following topics: •Basic water chemistry •Water quality selection criteria •EPA, EU, and WHO drinking water standards •The governing regulatory agencies with direct impact on water systems •Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups) •Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam) •Pretreatment component equipment - selection and operating principals •Final treatment options (reverse osmosis, vapor compression, single-effect and multiple-effect stills) •Opportunities for energy and water resource conservation •Point of use criteria such as temperature, location, time-of-day, and demand (GPM & GPD) •System design including materials of construction, generation, storage and distribution options •Trend reports (analysis, problem identification, predictive value) •Control systems, data historian, secure access, set points and alarms •Managing performance deviations and component failure •Direct and in-direct impact analysis •Quality by design including risk assessment •Instrument calibration for critical, non-critical, and informational only devices •Maintenance impacts to system performance, reliability, and validation •The importance of as-built documentation - user and field directed changes


2016 PDA Data Integrity Workshop

December 7-8, 2016

Manchester Grand Hyatt , San Diego, CA, United States

The 2016 PDA Data Integrity Workshop, offered several times in global locations, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.


Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment

December 7-9, 2016

The Desmond Hotel and Concerence Center, Malvern, PA, United States

This is a three-day course designed to provide individuals with an in depth understanding of the design, balancing, commissioning, operation and maintenance of HVAC systems in a regulated environment. The course consists of lectures and imbedded exercises. Participants will also be placed in several real life situations such as completing a compliance review of floor plans and air flow diagrams, room pressurization schemes, ductwork design, and air balance reports; conducting emergency egress analysis during a system failure; HVAC risk assessment; and change control analysis including the impact of modifications requested by the end user. The course is designed to provide the attendee with thorough knowledge of the following topics: •The governing regulatory agencies with direct impact on HVAC systems •FDA and EU classified space comparison •What constitutes Good Engineering Practice •The major components of an HVAC system •A high level overview of Psychrometrics •The engineering and design process •Latent and sensible loads •Types of systems – application and operation •Energy conservation measures and their impact on system performance •Ventilation requirements •Control set points and alarms •Air balancing – cascading air flows and room pressurization •Risk assessment for HVAC •Air filtration – from bird screens to terminal HEPA filters •Sources of air particle contamination •Room air-change rates – ISO standards •Room recovery period versus air change rates •Sterility versus containment •Humidity and temperature set points – range of control and tolerances •Instrument calibration – critical, non-critical, and informational •Maintenance impacts to system performance, reliability, and validation •Partnering with the system owner to obtain funding for major repairs, upgrades or wholesale replacement •Personnel safety and egress considerations •The importance of as-built documentation – user and field directed changes •The engineering turnover package (ETOP) and commissioning


11th annual Cold Chain Distribution

December 12-13, 2016

Park Plaza Victoria, London, Non-U.S., United Kingdom

Following the fruitful discussions in 2015, SMi's annual Cold Chain Distribution conference will bring back lively debates and industry updates to London, offering the best platform for delegates to stay ahead of this lucrative market! Benefits of Attending:

  • Hear from MHRA, PIC/S and Danish Medicines Agency on GDP updates to ensure compliance
  • Insights into emerging markets for cold chain distribution potential and challenges
  • Learn about the latest technologies in cold chain distribution, from temperature monitoring to packaging
  • Practical case studies - how to execute the last mile distribution and what are the new strategies to implement seamless cold chain distribution?
  • Evaluate your logistics planning with you 3PLs to drive operational excellence

Confirmed Speakers for 2016 Include:

  • Steve Todd, Senior GDP Inspector; Chair of GDP Expert Circle, MHRA
  • Andrea Gruber, Senior Manager, Special Cargo, IATA
  • Didier Basseras, Vice President, Global Head of Clinical Supplies - Clinical Supply Chain, Sanofi-Aventis
  • Gino Vleugels, Senior Manager EMEA Temperature Control, Johnson & Johnson
  • Yoram Eshel, Senior Director, Global Transportation and Logistics, Teva Pharmaceutical
  • Stephen Mitchell, Quality & Compliance Manager, Global Logistics, GSK
  • Saddam Huq, QA Senior Manager, Global Logistics & Cold Chain, GSK Biologicals
  • Thomas Vestergaard Pedersen, Medicines Inspector, Danish Medicines Agency
  • Tony Wright, CEO, Exelsius
  • David Spillett, Business Development Manager, World Courier
  • Fredrik Wildtgrube, Head of Global Sales, Finnair Cargo
  • Tim Holliday, Qualified Person, PCI Pharma Services
  • Mark Edwards, Managing Director, Modalis

and many more.


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March 2017

Pittcon 2017

March 5-9, 2017

McCormick Place, Chicago, IL, United States

Pittcon 2017 will be held March 5-9, 2017, in Chicago, Illinois, at McCormick Place West. Pittcon offers a unique, once a year opportunity to get a hands-on look at product innovations from leading companies and to learn the latest techniques from world-renowned members of the scientific community. Find solutions to all your laboratory challenges.


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