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January 2014

IFPAC 2014
January 21 - 24, 2014
Arlington, VA

IFPAC is the essential meeting place for the latest developments in Process Analytical Technology...PAT and Quality by Design...QbD within the Pharmaceutical, Biotechnology and related industries. IFPAC is known for being a collaborative forum to exchange ideas and network through panel discussions, poster sessions, and the exhibition. For over 25 years IFPAC has brought together practitioners from industry, academia and government to discuss new trends in technology, standards, and controls.

IFPAC-2014 will feature comprehensive Pharmaceutical/Biotechnology tracks including the topics: Real-Time Release, Continuous Manufacturing, Implementation for Drug Product Development and Manufacturing, Sampling/Content Uniformity, BioProcessing/BioTransformations, Real Time Monitoring of BioReactors/BioProcessing, Manufacturing-Science & Technologies in Biologics Manufacturing, Life Cycle Management of Models, Imaging, Particle Characterization, and various analytical techniques including: NIR, Raman, and Mass Spec.

Plus the latest in Contract Manufacturing & PAT, Risk Management, Using Process Capability to Ensure Pharma Product Quality-Industry and Regulatory Perspectives, Rapid Micro Methods for Manufacturing Roles, Continuous Process Verification, Question Based Review Approach, Experience with QbD Submissions Internationally, QbD and PAT in the Generic Industry and more...

IFPAC continues to attract high profile speakers from International and U.S. Regulatory Agencies, Universities/Research Institutions and Industry. IFPAC also offers a unique opportunity bringing together a blend of different fields to discuss common problems and solutions. Don't miss this opportunity to meet with new and existing colleagues from the pharmaceutical, biotechnology, food, generic, chemical, petrochemical and other related fields.

 

Informex USA
January 21 - 24, 2014
Miami Beach, FL

Informex USA is the only event of its kind offering exhibitors & attendees a direct view of what is happening globally across the fine, specialty & custom chemical marketplace. The event brings together an international mix of motivated buyers and sellers of high value chemistry for 4 days of sourcing, education & networking. 

 

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February 2014

Fermentation and Separation for the Food & Drug Industries Short Course
February 2 - 4, 2014

•  Provide practical training in the field of cell culture, bioreactor operation, bioprocess paradigm, and separation technology
•  Increase understanding of the industrial food & drug fermentation biotechnology through simulation, sterilization technologies and clinical implications as well as related research being done across different countries, universities, and industries
•  Review new technologies in the fermentation and separation biotechnology
•  Demonstrate a ”hand-on” pilot-scale experiments
•  Trends of industrial fermentation including biofuel across different countries, universities, and industries

Learn the latest technology and issues about food and drug fermentation biotechnology!!! Space is Limited. Registration is on a first-come, first-serve basis Academic Discounts Applicable!

For additional information, please contact Dr. Yongjae Lee; Head – Separation Science Program; Ph: 979/845-2758; Fax: 979/845-2744 E-mail: yongjaelee@tees.tamus.edu

 

18th Annual ARC Industry Forum: Industry in Transition: The Information Driven Enterprise in a Connected World
February 10 - 13, 2014
Orlando, FL - Renaissance Orlando Hotel

New information technologies such as cloud computing, mobility, social technologies, Internet of Things, big data/analytics, and 3D visualization have been getting a lot of attention in the industrial community as each has the potential to disrupt and radically change the way companies do business. Still, most industrial enterprises tend to be conservative and slow to embrace new information technologies. This go-slow strategy, however, can be far riskier than anticipated. New information technologies may disrupt not only what happens within a plant or facility, but entire business processes throughout the supply chain and across the value network. The business environment is increasingly dynamic and volatile. New business models such as “Industry 4.0”, “Industrial Internet”, “Connected Manufacturing”, and “Collaborative Value Networks” are emerging. In addition to a host of potentially disruptive technologies entering the marketplace, companies must also face rapid changes in government regulations, energy and raw materials availability, markets, and competition. By deploying leading edge information technologies, today’s companies can thrive.

 

Cost-effective auditing: Making the most of the time on-site
February 20, 2014
Online Event - ComplianceOnline

This training on clinical audit will teach attendees how to prepare for audit and ensure readiness at all times. Why Should You Attend: How effective are your clinical trial audits? Can you rapidly identify major issues that could negatively impact your ability to manufacture products? Audits can be challenging – there can be an adversarial undercurrent even before it starts. And rightfully so – there can be a lot on the line, such as continued business relationships and continued revenue streams. When to start an audit program is always a concern, especially in the early stages of product development – whether it is performed on the premises or off-site. By attending this webinar, the participants will learn how to prepare for a clinical trial audit so that one can maximize time and information gathering time during the audit. It will teach the attendees to manage the audit if participants show defensive attributes. Learn how to “pull the thread” and find out if what you see is reality. Assessing the significance of a finding, in the context of the operation and how to effectively communicate the concern can be challenging – be prepared to adjudicate the significance of each finding at the wrap-up meeting. 

2-day In-person Seminar on Computer System Validation - Reduce Costs and Avoid 483s
February 20-21, 2014
DoubleTree by Hilton Hotel Los Angeles Downtown -  Los Angeles, CA

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. The latter impact all areas of ICH Q9 and ICH Q10. 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. Consequently, the number of 483s / Warning Letters due to CSV continue to be on the rise. It is estimated that 1 in 5 of Medical Device Recalls are due to incorrect CSV. Currently, there are many outstanding Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) that include citations for CSV. This is expected to further escalate as technology advances and companies need to consider Cloud Technologies and, as well as patient privacy issues such as HIPAA Costs of not understanding CSV are enormous: One 2013 incorrect implementation of CSV resulted in fines of up to $3 Billion. Software Projects requiring CSV often overrun by several months. Corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found.

 

Webinar on Orphan drug regulation, value add IP? Better than Patents
February 26, 2014
Online Event - Global Compliance Trainings

We will look through the orphan drug regulations in the USA and EU, we will go through these very similar regulatory areas and look at the orphan opportunities in other parts of the world. We will go through each of the requirements and look at the ways in which they can be applied to your technology and the most common errors people make when applying.

 

 

 

Webinar on Design Control and the ICH Q 10 Pharmaceutical Lifecycle 
February 27, 2014
Online Event - Global Compliance Trainings

Design Control, often referred to as product quality planning, has been practiced for many decades. In fact, if you have ever taken part in the review and approval of a technical document, realize that product development occurs through several stages of development with increasing complexity, andhave been involved in the evaluation, testing, and analysis of these lifecycle stages, then you have been involved in and practiced Design Control. Design Control, in simple terms, is a systematic defined sequence of events that occur in the product development and commercialization to ensure that the product meets user requirements. The ICH Q10 Model defines the pharmaceutical lifecycle as consisting of four phases-product development, technology transfer, commercialization, and product discontinuation. Within each of these phases, there are defined cyclical and none-cyclical sequential events that must be directed and controlled in order to assure the successful design of products that meet or surpass user requirements. This webinar is intended to describe and explain these lifecycle phases, including the associated sub-routines. Using graphics, the inputs and outputs of each phase may be seen and studied thus providing a perspective of the relationship of the individual events to the pharmaceutical product lifecycle in its entirety.

2-day In-person Seminar on Clinical Trial Applications in Canada, and Comparison to US and EU at Toronto, Canada
February 27-28, 2014
Courtyard Toronto Downtown - Toronto, Alberta

This seminar will cover the organization of Health Canada as it relates to clinical trials and drug development, Canadian regulations governing the conduct of clinical trials in this country, the process for getting approval of clinical trials, requirements after approval of the trial, submission of safety data, inspections by Health Canada related to clinical trials, Good Manufacturing Procedures (GMP) requirements for clinical trials, the conduct of Phase IV clinical trials, and pending changes to the conduct of clinical trials in Canada. We will review requirements for drugs, biologics, gene therapy and natural health products. In addition, we will discuss the conduct of clinical trials in Canada to the conduct of such trials in the US or EU. Why you should attend: Conducting clinical trials is a global undertaking. Understanding the details of conducting such trials in Canada will enable companies to add Canadian sites to their global trials, and access the excellent network of researchers in this country. The FDA recognizes Canadian sites as US sites in their review of NDAs. Within Canada there are significant tax credits related to the conduct of clinical trials in this country. Canadian researchers and drug developers can best make use of these fiscal policies by understanding clearly how to conduct research in Canada. For Canadian companies it is important to understand how research is done in this country and how it compares to the US and EU. Raising money to fund research will require that you present clearly the strategy for development that you are following in Canada, the US and EU.

 

2-day In-person Seminar on Verification vs. Validation - Product Process Software and QMS at Las Vegas NV
February 27-28, 2014
Hilton Grand Vacations Suites at the Flamingo - Las Vegas, NV

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. 

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March 2014

Statistics for the Non-Statistician - 2-day In-Person Seminar
March 3 - 4, 2014
Hilton Zurich Airport - Zurich, Switzerland

Overview: Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by providing a basic overview of the most common statistical tools and terms. The course covers the use of statistical software packages and the role of software in statistical analysis and statistical process control. Areas addressed include how to use statistics to properly trend data, support the annual product review, justify process changes and set product specifications. By the end of day two, course participants will have acquired the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements. Throughout the duration of this intimate, hands-on course, participants will be able to interact with both an expert instructor and their peers.

Why you should attend: This course will help you to use statistics correctly and minimize compliance risk.

Who Will Benefit: This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies: Medical Device Diagnostic Supervisors Pharmaceutical Biologics fields The employees who will benefit include: Development Scientists Analytical Method Development QA/ QC personnel

DATE, VENUE & PRICE: Location : Zürich, Switzerland | 3rd & 4th March 2014| 9 AM to 6 PM Venue : Hilton Zurich Airport Address : Hohenbuehlstrasse 10, 8152 Opfikon Glattbrugg Zurich Switzerland Price: $1,595.00 Register now and save $200. (Early Bird) Until January 25, Early Bird Price: $1,595.00 From January 26 to March 01, Regular Price: $1,795.00 Location : Sao Paulo, Brazil | 6th & 7th March 2014| 9 AM to 6 PM Venue : WILL BE ANNOUNCED SOON Price: $1,595.00 Register now and save $200. (Early Bird) Until January 31, Early Bird Price: $1,595.00 From February 01 to March 04, Regular Price: $1,795.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link - http://bit.ly/1d0hO12 LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

ISA Food and Pharmaceutical Industries Division (FPID) Symposium
March 5 - 6, 2014
ISA Headquarters - Research Triangle Park, NC

The symposium will bring together experts, vendors, and end users in a 2 day symposium to cover the important issues of automation and serialization and their impact on the secure pharmaceutical and food supply chain. Recent legislation and incidents of contamination and tampering have raised the importance of automation to reduce errors and implement serialization to improve tracking and tracing throughout the supply chain. The symposium will put out a call for papers that cover the following topics; Serialization, Track & Trace, Validation, Cyber Security, RFID, PAT, QBD, Virtualization, Batch Controls, MES, and automation project management.

Statistics for the Non-Statistician - 2-day In-Person Seminar
March 6 - 7, 2014
Sao Paulo, Brazil

Overview: Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by providing a basic overview of the most common statistical tools and terms. The course covers the use of statistical software packages and the role of software in statistical analysis and statistical process control. Areas addressed include how to use statistics to properly trend data, support the annual product review, justify process changes and set product specifications. By the end of day two, course participants will have acquired the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements. Throughout the duration of this intimate, hands-on course, participants will be able to interact with both an expert instructor and their peers.

 

Acceptance Sampling - Methods and Applications - 2-day In-Person Seminar
March 6 - 7, 2014
Courtyard Boston Logan Airport - Boston, MA

Overview: Many companies use acceptance sampling as a standard business practice. The most common applications use attribute sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common methods are not always the best approaches. This seminar will expose to you to a variety of methods and help you understand when to use them. While many of the examples come from medical device manufacturing because of the rigid regulatory structure, the methods apply in aviation, defense, and other manufacturing settings. This unique hands-on course provides attendees with a solid understanding of acceptance sampling methods and their application to manufacturing. The course delivers tools, templates, and insight that will allow participants to choose and implement the best sampling methods for their application. Many companies have procedures and programs that fall short of the regulatory requirements and good statistical practice. In some cases, FDA may give the firm a 483 or even a Warning Letter. QMS audits may result in nonconformances that need to be addressed. In other cases, the firm may not use the best methods, resulting in waste of resources. This two-day hands-on course provides a clear understanding, with many exercises, of the methods and underlying statistics for acceptance sampling. As part of the practical implementation, the course explains common standards such as Z1.4 for attribute sampling and Z1.9 for variables sampling. In addition, the course covers other, less well know, methods such as sequential sampling, continuous sampling, and chain sampling. The course also covers specific applications of sampling including incoming inspection, design validation, design verification, process validation, and quality audits.

Who Will Benefit: Quality Managers Quality Engineers Supplier Quality Engineers Quality Analysts Production and Process Engineers Design and Development Engineers Verification and Validation Specialists

 

Writing and Managing SOPs Effectively for GMP Operations - 2-day In-Person Seminar
March 13 - 14, 2014
Los Angeles, CA

Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.

Why should you attend: SOPs are important in pharmaceutical industry. Most of GMP violations are due to inadequate SOPs or SOPs that are not well written. Any critical GMP activities that affect quality and safety of the drug products will require written procedures. This course will provide participants with tools to write effective SOPs. This course will also discuss the regulatory requirements of documentation and record management systems for SOPs used in GMP operations. This 2-day course will emphasize practical issues such as the role of SOP in GMP operations, how to improve and maintain existing documentation system, and how to determine gaps or overlaps to strengthen the existing system. After this course, you will be able to understand the critical role SOPs play in daily operation, strengthen and maintain your current SOP system and organize effective training for SOPs.This course is filled within interactive exercise to help participants develop practical understanding of this important tasks and a logical approach to develop their own SOP system.

Date, Venue & Price: Location: Los Angeles, CA | 13th & 14th March 2014| 9 AM to 6 PM PDT Venue WILL BE ANNOUNCED SOON Price: $1,295.00 Register now and save $200. (Early Bird) Until January 31, Early Bird Price: $1,295.00 From February 01 to March 11, Regular Price: $1,495.00 Location: Philadelphia, PA | 17th & 18th April 2014 | 9 AM to 6 PM EDT Venue : DoubleTree by Hilton Hotel Philadelphia Center City Price: $1,295.00 Register now and save $200. (Early Bird) Until March 10, Early Bird Price: $1,295.00 From March 11 to April 15, Regular Price: $1,495.00 Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link: http://bit.ly/1eWX2lm LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

MODEX 2014
March 17 - 20, 2014
Georgia World Congress Center - Atlanta, GA

MODEX 2014® is the industry's newest expo for the manufacturing and supply chain industries. It’s where the best and brightest thinkers in the supply chain gather to discuss the trends of today and the challenges of tomorrow. At MODEX you will meet 800 of the leading providers and see their solutions in person, in action.

INTERPHEX 2014
March 18 - 20, 2014
Javits Center - New York, NY

IINTERPHEX is THE single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms for life-enhancing drugs. Taking place March 18-20, 2014 at the Javits Center in New York City, you will find: the latest pharmaceutical and biomanufacturing technology from 650 vendors, fresh ideas and inspiring education by PDA (Parenteral Drug Association), IPS Technologies flour tour showcasing the latest equipment and innovations and networking opportunities with the industry.

IBC’s Biopharmaceutical Development & Production Week
March 24 - 27, 2014
Hilton, Bayfront Hotel – San Diego, CA

IBC’s Biopharmaceutical Development & Production (BDP) Week event provides the most in-depth coverage of bioprocessing methods in the field, to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline.

9 Conference tracks:
• Upstream Processing • Downstream Processing • Analytical Technologies • Viral Safety • Process Validation • Contract Manufacturing & Technology Transfer • Manufacturing Efficiencies • Antibody Drug Conjugates • Raw Materials/Supply Chain

By attending this event, you will learn about challenges and successes in process development and clinical/commercial manufacturing for a wide variety of molecules including mAbs, vaccines, ADCs, recombinant proteins, bispecifics, enzymes, biosimilars and cell/gene therapy products. You will also benefit from numerous networking opportunities including poster sessions, interactive discussions and the BDP Week Beach party!

Special Pharmaceutical Manufacturing Savings
To save 20% off the standard rates register with priority code BDP14PM. Register online at: http://bit.ly/JPX5GJ or by calling 800.390.4078. This offer is only available for new registrations and cannot be combined with other offers.
Download the event brochure (PDF): 

 

The 4th Nextgen China 2014
March 27 - 28, 2014
Shanghai, China

The 4th NEXTGEN CHINA 2014 will be held on 27-28th in Shanghai China. This summit which focuses on the theme that seizing initiative in changing regulation & market environment and improving generic drug quality will gather all resource of CPhI global and essence of past three conferences, and explore regulatory, market & technology in generics to discuss and showcase evolving generics landscape & solutions.

 

ISPE Statistician Forum - Use of Statistics in Support of the Lifecycle Approach to PV
March 31, 2014
The Westin Philadelphia - Philadelphia, PA

Key Presentations from FDA’s Grace McNally and Karthik Iyer

• Take advantage of this open forum to address how the industry is using statistics in Process Validation and Implementation.
• Influence the direction and industry Best Practice for use of statistics to support lifecycle approach to Process Validation. 
• Gain greater clarity on the significant differences of opinion that still exist regarding the meaning and intent of FDA’s statistical expectations.
• Participate in interactive and open discussions on every topic.

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April 2014

NASP 2014 Specialty Pharmacy EXPO
April 1 - 4, 2014
University of South Florida, Center for Advanced Medical Learning and Simulation - Tampa, FL

The NASP Specialty Pharmacy EXPO convenes leaders and decision makers from the Specialty Pharmacy industry to discuss the latest issues and trends. It offers valuable networking opportunities with colleagues and exhibitors as well as educational sessions utilizing the CAMLS Center’s 35 simulation-based meeting rooms to host reimbursement workshops, clinical workshops, and patient interaction labs to demonstrate best practices utilizing practice parameters. The CAMLS facility includes 90,000 square feet of meeting space that integrates simulation technology to create a unique learning and networking environment. This technology gives NASP attendees the opportunity to become fully engaged with the programming using a virtual inpatient and outpatient pharmacy and simulated patient/emergency rooms for interactive training in therapeutic areas such as HAE, SCIG/IVIG, oncology Hep C and others.

2014 PDA Annual Meeting
April 7 - 9, 2014
San Antonio, Texas | JW Marriott San Antonio Hill Country

Hear from experts in supply chain, environmental controls, new therapies, personalized medicines, biosimilars, along with many other important topics.

 

PDA Bioburden and Biofilm Workshop
April 9 - 10, 2014
San Antonio, Texas | JW Marriott San Antonio Hill Country

This workshop will present practical approaches to the prevention, detection, and remediation of microbial contaminations that attendees can use in daily production and laboratory operations.

 

ISPE San Francisco Training
April 14-17, 2014
Burlingame, CA -Hilton San Francisco Airport Bayfront - Burlingame, CA

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE Auditing, Biopharmaceutical Manufacturing, C&Q, GAMP5, Pharmaceutical Water, Project Management, and QRM.

 

Membrane & Other Separation Technologies Short Course
April 27 - May 1, 2014

  • Review basic principles of membrane filtration & separations processing
  • Orient new product formulators, food scientists, chemists, chemical engineers, environmental engineers and students in food, dairy, and beverage industry
  • Provide daily “hands-on” pilot plant demonstrations
  • Review new technologies / developments in membrane filtration technology & separations technologies

Please visit our website: http://foodprotein.tamu.edu/separations/scmembrane.php

ISPE Europe Annual Conference – Driving Effectiveness in Pharmaceutical Operations within the new Quality Culture
April 28-30, 2014
Sheraton Frankfurt Airport Hotel & Conference Centre - Frankfurt, Germany

Who Should Attend? The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with Interest in New Solutions and Experiences. Keynote speakers from industry and regulatory authorities will define the New Quality Culture and share their perspectives.

 

Webinar on Control of Drug-related Impurities, Degradants and Potential Genotoxic Impurities in Drug Substance and Drug Product
April 29, 2014
Online Event - Global Compliance Trainings

Description: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities, degradants and potential genotoxic impurities in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants.

 

 

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May 2014

2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems
May 1-2, 2014
DoubleTree by Hilton Hotel San Diego Downtown - San Diego, CA

Description: 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 you should 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.

Hands-on Tablet Development, including Pre-formulation, Formulation and Process Development
May 4-5, 2014
Country House - Beckenham, UK

This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. Each day will consist of lectures on aspects of tablet development, followed by linked sessions in which participants take part in related experimental work. The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).

CHI's Biologics Formulation & Delivery Summit
May 5-7, 2014
Seaport World Trade Center - Boston, MA

HI’s Inaugural Biologics Formulation and Delivery Summit will provide a forum for focused discussions on current challenges and opportunities in delivery of biotherapeutics. This two-part summit will discuss various formulation and device-based approaches for designing physiologically relevant, patient friendly, targeted biologics products: Formulation Strategies for Improved Delivery of Biologics (May 5-6) and New Technologies for Biologics Delivery and Targeting (May 6-7).

International Powder & Bulk Solids Conference 2014
May 6 - 8, 2014
Donald E. Stephens Convention Center - Rosemont, IL

International Powder & Bulk Solids (PBS) Conference/Exhibition is the gathering place for dry processing and bulk solids handling professionals. PBS delivers industry-leading education, the latest in equipment and product enhancements, and extensive peer-to-peer networking opportunities. Meet with the world's top authorities in the science of dry processing providing insight and showcasing the latest product trends. PBS promises to deliver immediate access to the knowledge, tools, and technologies you need, and will surprise you with new ideas for efficiency and quality.

Whether you need to transport, analyze, weigh, batch, mix, grind, dry, shape or package you'll find the solution HERE! Attending the show helps you:

  • Keep pace with global competition
  • Get quality face time with technical experts
  • Find suppliers with years of experience
  • The International Powder & Bulk Solids Conference 2014
  • Maximize your time

 

2-day In-person seminar on Effective Complaint Handling, Medical Device Reporting and Recalls
May 8-9, 2014
Hilton Garden Inn Baltimore - Baltimore, MD

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. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

 

interpack 2014
May 8 - 14, 2014
Düsseldorf, Germany - Düsseldorf Fairgrounds

Held every three years, interpack is the world’s leading trade fair for the packaging industry and all related process technologies. About 2,700 exhibitors from more than 60 countries will present their latest ideas, innovative concepts and technological visions at interpack - not only in equipment and machinery for packaging and processing, but also in production tools for packaging materials, materials themselves, and services for the entire industry. The 2011 show brought 166,000 visitors from around the world. A new event will also be held in 2014: “Components for Processing and Packaging,” which will take place on the first three days of interpack in the Congress Center South at the Düsseldorf fairgrounds. The trade fair is geared toward suppliers to the packaging insdustry, specifically companies specializing in motor, drive, control and sensor technology, products for machinery image data processing as well as handling technology, industrial software and communication, and complete automation systems for packaging machinery. It is also directed at manufacturers of machinery parts, components, accessories, peripheral equipment and components, and auxiliaries for packaging material. For more information, click here.

Impurities In Pharmaceuticals
May 14-15, 2014
Marti Hotel, Taksim - Istanbul

This 2-days seminar will help define the different sorts of impurities that may occur in drug substances and finished dosage forms. It will help in differentiating between degradation products and other impurities and will look at the requirements for determining degradants through the use of validated analytical methods incorporated into regulated stability testing programs in accordance with ICH/EMA and revised FDA requirements... For more information and event brochure, please visit www.mkistanbul.com

2014 PDA Knowledge Management Workshop - Enabler for ICH Q8 - Q11, QRM and Continued Process Verification
May 19 - 20, 2014
Bethesda, MD | Hyatt Regency Bethesda

This is the workshop to attend if you want to treat knowledge as an important asset for your organization, and how to implement a program to capture and manage knowledge to achieve its full benefit.

 

ISPE Brussels, Belgium Training Event
May 19-22, 2014
Sheraton Brussels Hotel - Brussels, Belgium

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE HVAC, Cleaning Validation Principles, Risk-MaPP, Basic Principles of Computerized Systems Compliance, Process Validation/PQS, Risk-based and FSE.

 

ISPE Indianapolis Training Event
May 19-22, 2014
Indianapolis Marriott Downtown - Indianapolis, IN

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE Oral Solid Dosage Forms, Sterile Mfg., Clinical Trial Materials, Control for Critical Environments, Cleaning Validation Principles, Basic Principles of CSC Using GAMP5, and PV/PQS.

 

2014 PDA Packaging Conference
May 20 - 21, 2014
Washington, DC | Washington Marriott Wardman Park

This conference will provide perspective on the dynamics for selecting and qualifying packaging systems throughout the pharmaceutical product lifecycle for the safe and effective delivery of medicines to patients.

Webinar on Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation and Transfer
May 20, 2014
Online Event - Global Compliance Trainings

This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically. This approach will be linked with current compendial requirements. There will be an opportunity for questions and answers at the end of the presentation.

Pharmaceutical Microbiology
May 27, 2014
Marti Hotel, Taksim - Istanbul

The course will instruct delegates in basic microbiology, including: Microbial families and the Microbial World. What impact they have on production and products. Discuss the role of the microbiology lab, appropriate tests and requirements. Review personnel and facility hygiene. Review of regulatory expectations of the microbiological control of production processes and facilities. We will also discuss microbiological control of water systems used in the Pharmaceutical Industry, including endotoxins.



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June 2014

2014 PDA/FDA Pharmaceutical Supply Chain Conference
June 3 - 5, 2014
Washington, DC | JW Marriott Washington D.C

Hear regulators and industry experts present on an array of topics addressing practices and approaches to be considered to ensure the integrity and quality of the global pharmaceutical supply chain.

2014 PDA/FDA Virus & TSE Safety Conference
June 9 - 11, 2014
Bethesda, MD | Hyatt Regency Hotel

Presentations and panel discussions from regulatory and industry representatives from around the world will cover emerging virus detection methods, consider virus safety risks associated with biological reagents used during expression cell cloning, the risk associated with new cell substrates as well as bioreactor contamination risks and risk mitigation measures.

Biosimilars - Commercial & IP Considerations
June 11, 2014
Marti Hotel, Taksim - Istanbul

This 1-day seminar on Biosimilars will look at all aspects of biosimilars in both highly regulated and less regulated markets, including the EU regulatory landscape and how it has helped the biosimilar market to develop a long way ahead of the US... For download brochure please visit our web site.

 

ISPE Atlanta Training Event
June 12, 2014
Crowne Plaza Hotel Atlanta Airport - Atlanta, GA

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE Oral Solid Dosage Forms, Sterile Mfg., Tech Transfer, C&Q, QbD, Basic Principles of CSC Using GAMP5, and Combination Products.

RSTechED USA
June 15-20, Orlando

RSTechED is a training event for end-users, systems integrators, partners and OEMs. With the latest Rockwell Automation products and technology solutions on display, participants will gain an in-depth understanding of how the Integrated Architecture is information-enabling global companies. Register for this event and learn more.

2014 PDA Aseptic Processing-Sterilization Conference
June 17 - 18, 2014
Chicago, IL | Hyatt Chicago Magnificent Mile

This two-day conference will provide participants with a comprehensive review of contemporary practices for the conduct of terminal sterilization and aseptic processing with special emphasis on state of the art approaches, sterilization-related quality metrics, risk assessment/mitigation, and novel sterilization methodologies.

Sensors Expo & Conference
June 25 - 26, 2014
Rosemont, IL | Donald E. Stephens Convention Center

Sensors Expo & Conference is the only industry event in North America exclusively focused on sensors and sensor-integrated systems, providing nearly 30 years of technical innovation and thought leadership! The conference program is dedicated to exploring the most up-to-date innovations in sensor technology, including MEMS, Energy Harvesting, Internet of Things (IoT), Wireless, Sensor Fusion, Sensors @ Work, Measurement & Detection, and more. Sensors Expo & Conference identifies cutting-edge trends, explores them in an information-packed conference program and reflects those trends throughout the exhibit floor with new product announcements, key technology-focused areas, such as Energy Harvesting, IoT MEMS and Wireless, and a showcase of hundreds of products and services. Visit www.sensorsexpo.com to register today and for the latest information on the 2014 event.

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July 2014

Lyophilisation 2014: Pharmaceutical and Biopharmaceutical
Hosted by SMi Group
July 7 - 8, 2014
Marriott Hotel Regents Park - London, UK

The global lyophilisation for pharmaceuticals products and services market is predicted to reach $3.09bn in 2014 with revenues showing strong growth to 2024. With increasing numbers of proteins being discovered, the importance of lyophilisation is coming to the fore, for example, as a means of extending the shelf life of pharmaceutical and biopharmaceutical products. SMi invites you to attend the 2nd annual Lyophilisation conference on 7-8 July 2014, London. This event will provide an update on methodologies for lyophilisation and examine how to mitigate risks in production. Join our Lyophilisation forum and gain insight into current successes and challenges faced by pharmaceuticals and biopharmaceuticals during their freeze-drying life cycle. For additional information, please contact John Collins: +44(0) 207 827 6734 E-mail: jcollins@smi-online.co.uk

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September 2014

WTG Global Pharma Manufacturing Summit 2014
September 8 - 9, 2014
The Westin Copley Place, Boston MA

The Global Pharma Manufacturing Summit has grown into the premier networking opportunity for industry leaders in small molecule and biologic pharmaceutical manufacturing. Manufacturers are facing increasing pressure to grow and evolve beyond strategies of the past. New technologies, heightened regulatory guidelines, and the oncoming wave of generic products are shaping a new exciting chapter for the industry.

Key themes in this year’s agenda include:

  • Emerging markets
  • Cost reduction
  • Quality management
  • Manufacturing excellence
  • Outsourcing and contract manufacturing

2014 PDA/FDA Joint Regulatory Conference
September 8 - 10, 2014
Washington, DC | Renaissance Washington Hotel

This conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today's leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.

ISPE Philadelphia Training Event
Sept 8-11, 2014
The Westin Philadelphia - Philadelphia, PA

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE: Pharmaceutical Water Generation, HVAC, Cleaning Validation Principles, Storage, Delivery & Qualification of Pharma Waters, An Overview of Biopharmaceutical Manufacturing Processes, Process Validation in Biotechnology Mfg., and Risk Based FSE.

2014 PDA Drug Shortage Workshop
September 10 - 11, 2014
Washington, DC | Renaissance Washington Hotel

This workshop will explore application of risk and knowledge management for addressing drug shortages, incentives for manufacturers to build in proactive controls such as redundant capacity and new technology, more transparency and linkages to supply planning, manufacturing site metrics and quality status for potential manufacturing partners, purchasers, and prescribers.

ISPE Barcelona, Spain Training Event
Sept 10, 2014
Hilton Diagonal Mar Barcelona - Barcelona, Spain

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE Risk C&Q, GxP Process Control Systems, Project Mgmt, QRM, Sterile Mfg., and Technology Transfer

 

2nd Annual Congress of the European Society for Translational Medicine & Global Network Conference on Translational Medicine (EUSTM-2014)
September 22 - 25, 2014
Vienna, Austria |  Schönbrunn Palace Conference Centre

 

3rd International Summit on GMP, GCP & Quality Control
September 25 - 26, 2014
Valencia Convention Center - Valencia, Spain

We cordially invite all the participants who are interested in sharing their knowledge and research in the field of Pharmacy. After a successful conference in 2013, which tracked the evolution of GMP, GCP we would like to invite you to participate in 3rd International Summit on GMP, GCP & Quality Control Slated on September 25-26, 2014, at Valencia Convention Center, Spain. This event will provide a broad ranging platform for informative and interactive discussions with contributions by recognized experts from: Industry Regulatory Authority Academia This year the annual conference will provide an A to Z perspective of the pharmaceutical production process from API to formulated product. The performance of the pharmaceutical production cannot be improved significantly if you do not look at it holistically. The main theme of the conference is “Manufacturing and Quality Guidelines; Training and Beyond”.

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October 2014

2014 PDA Universe of Prefilled Syringes and Injection Devices
October 6 - 8, 2014
Huntington Beach, CA | Hyatt Regency Huntington Beach Resort and Spa

This brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, challenges and industry trends in this exciting area.

PDA Human Performance & Human Factors Conference
October 13 - 15 2014
Bethesda, MD | Hyatt Regency Bethesda

The conference will provide opportunities for networking with others in the industry, including those with many years’ experience in this field, workshops, and ways to share best practices. Officials from regulatory agencies like US FDA will present their views of what is expected and situations where those expectations have not been met.

PDA 9th Annual Global Conference on Pharmaceutical Microbiology

October 20 - 22 2014

Bethesda, MD | Bethesda North Marriott Hotel & Conference Center

This conference will bring together all levels of industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces on a daily basis.

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November 2014

AAPS Annual Meeting and Exposition
November 2-6, 2014
San Diego Convention Center - San Diego, CA

The AAPS Annual Meeting and Exposition, a premier event in the pharmaceutical sciences industry, draws attendees from around the world who are involved in all phases of drug development. The AAPS Annual Meeting and Exposition showcases late-breaking research, validates scientific methodology and reveals the latest technology, services and supplies. Speakers include scientists from the Food and Drug Administration, US National Institutes of Health, leading pharmaceutical companies and academia.

2014 ISPE UK Affiliate Annual Conference, Table Top Exhibition and Awards Dinner
November 13, 2014
Hilton Brighton Metropole Hotel - Brighton, UK

Conference and Table Top Exhibition “Are the GMP’s for the 21st Century Delivering?” In 2002 the FDA launched the initiative - “Pharmaceutical GMPs for the 21st Century; A risk-Based Approach” and during 2003, a series of road shows were held throughout the US and Europe. The focus was firmly on the “science of manufacture”. Since that time, a number of guides and regulations were introduced and/or updated to incorporate the risk based approach. Further, initiatives such as “Integrated commissioning & qualification”; “Good Engineering Practice”; “Impact & Risk Assessments”; “PQLI” and the like have all impacted the pharmaceutical arena, but after 10 years has all this really had the effect that the regulator and the industry anticipated? This year’s ISPE UK Affiliate Annual Event will explore, through case studies, whether the FDA initiative has actually delivered the initial objectives of the initiative. ISPE UK Annual Awards Dinner The Conference and Table Top Exhibition will once again be followed by the illustrious ISPE UK Awards Dinner. The evening will begin with a drinks reception and end with after-dinner entertainment. The ISPE UK Awards Dinner is a fantastic networking opportunity and regarded as a principal event in the pharmaceutical engineering calendar.

 

ISPE Raleigh Training Event
Nov 17, 2014
Hilton North Raleigh/Midtown - Raleigh, NC

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE Pharmaceutical Water Generation, Computerized Systems Compliance, Clinical Trial Materials, HVAC, Storage, Delivery & Qualification of Pharma Waters, Project Management, and Biotechnology Mfg.

Pharmingredients+
Nov 25, 2014
Moscow - VVC

The industry-leading Pharmtech exhibition of technologies for the pharmaceutical industry will feature an event taking place alongside it – Pharmingredients+, an exhibition of raw materials and ingredients for pharmaceutical production. Pharmingredients+ will take place in Pavilion 75 of VVC in Moscow. The purpose of the Pharmingredients+ exhibition is to reflect the rising role of high qualtiy active pharmaceutical ingredients and functional ingredients in the production of modern medical substances. Exhibitors will include Russian and international producers and suppliers of pharmaceutical substances, materials, ingredients and auxiliaries, and also development, analysis and registration companies. Professionals working in medicine, bio-active supplements and veterinary drugs will have an opportunity to make direct contacts and discuss future cooperation.

 

Pharmtech
Nov. 25-28, 2014
Moscow - VVC

Established over 15 years, Pharmtech is the pharmaceutical industry’s annual meeting place, where the latest products, technologies and techniques forpharmaceutical production are on display, and established names in the industry both in Russia and abroad can meet pharmaceutical producers from Russia and Central Asia. As the only show dedicated to this important industry in Russia and CIS, Pharmtech brings together 324 exhibitors from 27 countries. Visitors to the event gain invaluable information about the pharmaceutical industry in Russia, which will help them to build their businesses and improve the quality of pharmaceuticals in Russia. The PharmTechProm Forum features presentations and seminars from leading specialists in the industry and, in 2013, a special focus was given to innovative products, processing technologies and plans for market development.

 

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December 2014


ISPE Tampa Training Event
December 1-4, 2014
Embassy Suites Tampa-Airport/Westshore - Tampa, FL

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE: GMP Auditing, Cleaning Validation, Risk PCS, Q7A, Risk MaPP, QRM, and PV/PQS.

 

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