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- June 2010
- July 2010
- August 2010
- September 2010
- October 2010
- November 2010
- December 2010
- January 2011
- February 2011
June 2010
Practical Methods for Project Management
June 3 - 4, 2010
King of Prussia, Pa.
This workshop will be of great value to those in the life sciences, consumer products and food and chemical industries who are responsible for directing projects within their areas of expertise. This is especially valuable for technical personnel with little or no experience managing complex projects. Upon completion of this course, attendees will have a strong understanding of the principles and practices of project management, including how to: work with the sponsor to start the project off in the right direction; become a better project leader; lead a team through a collaborative planning process and maintain team member accountability during project execution. Visit www.cfpie.com/showitem.aspx?productid=060&source=pharmaman for details.
June 7 - 9, 2010
Donald E. Stephens Convention Center - Rosemont, IL
For 24 Years, Sensors Expo & Conference Has Been the Leading Industry Event Focusing Exclusively on Sensors & Sensor-Integrated Systems! The in-depth conference program features the world's leading authorities, in a carefully designed program, including topics such as: Energy Harvesting, Wireless Networking, Low-Power Sensing, Bio-Sensing, MEMS & MCUs, Monitoring Tools & Applications, Novel Approaches to Measurement, Power/Smart Grid Monitoring & Control, and more! PLUS - save months of time researching, by examining solutions to your toughest sensing challenges from best-in-class vendors on the Expo floor! Whether you're looking to find the latest sensing solutions, evaluate emerging standards, find and compare suppliers, or solve new design challenges, you can't afford to miss Sensors Expo & Conference! Visit www.SensorsExpo.com for details!
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
June 10 - 12, 2010
Costa Mesa, Calif.
This two-day course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The course covers regulatory expectations regarding validation as contained in U.S. and international regulations. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention. This course will prepare attendees to plan and execute effective and compliant method validation plans. There will be an opportunity to apply what you have learned in a validation workshop. For more information, visit the event website.
Global Outsourcing Conference with FDA and Global Regulators
June 13 - 16, 2010
Xavier University’s Cintas Center, Ohio
Global Outsourcing is perhaps one of the hottest topics in the pharmaceutical industry today, and nowhere is that more evident than in the response to Xavier University’s call for speakers for its upcoming Global Outsourcing Conference. The Global Outsourcing Conference, to be hosted June 13-16, 2010 at Xavier University’s Cintas Center, is co-sponsored by Xavier University and the U.S. Food and Drug Administration (FDA). For more information, visit the event website.
June 13 - 17, 2010
Washington, D.C.
The DIA Annual Meeting is the premier event for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. There is no other industry meeting of its kind that can rival the breadth and depth of experience that this meeting delivers. With 25 content-area tracks, 350 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels. The DIA Annual Meeting, above all others, offers valuable professional cross-functional learning and networking experiences.
This program is designed for individuals involved in the involved in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products. The program is intended to strengthen professionals' understanding of the value of cross-discipline integration and to foster innovation for better health outcomes. For more information, visit the event website.
The 5th Annual Global Pharma Manufacturing Summit 2010
June 14 - 15, 2010
Boston, Massachusetts
Global Pharma Manufacturing is the event for small molecule manufacturers to debate both strategic and technical issues facing the industry. Leading professionals from Novartis Pharma AG, Novo Nordisk Pharmaceuticals and GlaxoSmithKline will be presenting over the two day event. This Pharma Manufacturing event provides a unique opportunity to hear the latest trends in drug manufacturing and network with leading industry peers. For more information, visit the event website.
Bio Production Forum — Fill and Finish for Biopharmaceuticals
June 15 - 17, 2010
Geneva, Switzerland
On 15-17 June 2010, the 6th Bio Production Forum takes place in Geneva, Switzerland. It is an Event with tradition that was organised successfully in Schaffhausen, Switzerland the last five years. As an innovative event focussing on an innovative industry, we like to change the venue towards Geneva, and are happy to provide the participants a new insight in the field of biopharmaceutical manufacturing by visiting the Merck Serono site, Aubonne. For more information, visit the event website.
114th Annual Educational Conference of the Association of Food and Drug Officials
June 19 - 23, 2010
Norfolk, VA USA
This conference is a forum for delegates from the United States, Canada and Mexico for discussion of cutting-edge food and drug safety, security and defense initiatives. For more information, visit the event website.
The 9th Annual Biological Production Forum 2010
June 21 - 23, 2010
Frankfurt, Germany
This is the event focusing on both upstream and downstream processing for biological manufacturing, production and cGMP specialists. Over the course of this 3 day event, you will take part in a mixture of networking and conference session featuring the latest strategies and industry case studies. Included in the event this year is the opportunity to take part in a tour at Merck KGaA’s head quarters. It is a unique day which will give delegates the chance to be one of the first to tour their brand new Process Solutions and also learn about the latest advancements taking place there. For more information, visit the event website.
The Drug Development Process - From Discovery to Commercialization
June 23 - 25, 2010
King of Prussia, Pa.
This course provides an understanding of the interrelated activities throughout the drug development cycle, and is designed for R&D, operations, marketing and sales management. This course serves as an introduction to the drug development process and will familiarize participants with the steps involved in developing a drug from discovery to commercialization. Included is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. In addition, this course covers sales planning and the commercialization decisions that affect the development of the drug. For more information, visit the event website.
Global Pharmaceutical Contract Manufacturing 2010
June 28 - 30, 2010
London, UK
The leading annual worldwide meeting for contract manufacturing stakeholders. Driving efficiency on your contract manufacturing sourcing and management to ensure high quality and timely supply.
Now in it’s 3rd year, Pharma IQ’s Global Pharmaceutical Contract manufacturing event will again deliver you the opportunity to hear first hand experience of outsourced manufacturing from both the pharmaceutical and CMO viewpoint. This is no one-sided partnership and the event is valuable opportunity to discuss and network with key professionals from both sides of the coin through our tailored presentation, group discussion and networking sessions.
As pharmaceutical companies are shifting focus to increase the number of products being brought onto the market by in-licensing and mergers and acquisitions, the number of products with external supply chains has risen. With these products now starting to make up a large proportion of the pipeline it is important that the external manufacture is successfully maintained through correct relationship management, KPI monitoring and risk mitigation.
Speakers at the conference include Joaquin Santos, GPSG, Senior Director External Manufacturing; EMEA Region, Johnson and Johnson, Béatrice Serckx-Poncin, Associate Director, Drug Product Industrial Strategy and CMO management, UCB, Kim Steffensen, Department Head Contract Manufacturing & Licensing, Novo Nordisk , Richard Fazackley, Associate Director, Product Realisation, Eisai , Dr Ulrich Rumenapp, Head Biotech Projects, Bayer Schering Healthcare AG and Jim Browne, Director, Contract Manufacturing, Europe, GlaxoSmithKline. For more information, visit the event website.
July 2010
Validation of Computer Systems
July 12 & 13, 2010
King of Prussia, PA
This course is designed for Validation, Quality, IT, and business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. Participants will gain a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. Attendees will be familiar with expected content for computer validation deliverables through examination of example documents, as well as, how to develop the validation rationale for a variety of circumstances. For more information, visit the event website.
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
July 12 & 13, 2010
King of Prussia, PA
This two-day course is meant for those who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot, or commercial setting. Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing, and provides practical advice for attendees to troubleshoot and manage their aseptic operations. For more information, visit the event website.
July 14 - 17, 2010
Hyderabad, India
India's economy has managed to emerge out of the global economic turmoil more or less unscathed largely because of its healthy domestic demand. While this trend augurs well for the growth of the industrial companies in India, they have to reckon with the reality that the demand-centric Indian market will lure leading global companies. At the global level, many industries such as automotive, cement, chemicals, steel, and others are saddled with excess production capacities. And these are the very industries that are set to witness massive expansion in India. Industrial facilities are built to operate over many decades and are highly capital intensive. Maintaining and managing these assets throughout the plant lifecycle plays an important role in realizing the returns and the role of asset management systems has to be recognized. ARC's Achieving Business Excellence through IT & Automation Solutions Forum will include two different programs over the four days. The first program on July 14-15 will focus on the electric power and water industries. The second program on July 16-17 will focus on process and batch industries. For more information, visit the event website.
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
July 15 & 16, 2010
Costa Mesa, CA
Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend this course. This two-day course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management. Upon completion of this course participants will be able to increase your ability to implement efficient practices that meet full GLP/GMP/ICH, ISO, and other regulatory requirements. For more information, visit the event website.
Fundamentals of Blending, Compression and Coating of Tablets and Tooling
July 20 - 22, 2010
St. Charles, MO USA
This course is designed for individuals in the tablet manufacturing industry that desire to improve their fundamental skills. For more information, visit the event website.
ARC's Twelfth Annual Forum in Asia
July 23, 2010
Tokyo, Japan
Reduce costs, reduce risk, reduce project cycle time, reduce energy use, reduce carbon footprint! These are key challenges for all manufacturing and asset-intensive organizations today. New business models, products, processes, and production techniques are needed as key drivers to sustain manufacturing enterprises to challenge the new paradigm of the post-global economic crisis.
At this Forum, you will learn:
* How emerging markets such as China, India, and Brazil are faring, along with the global market.
* What others do to create performance-driven, flexible, and higher-margin operations.
* How companies manage their manufacturing processes in order to leverage global engineering services
* Best practices to manage plant operations in an efficient and environmentally-friendly manner.
* The latest strategies for asset lifecycle management, asset performance management, and asset information management.
* The vision and technology roadmaps of the leading companies in wireless, digital manufacturing, cloud computing in manufacturing, etc. Over 200 top industry executives will get together to explore the strategies, technologies, best practices for success in manufacturing. Join us in Tokyo as we address the crucial challenges facing manufacturers today.
For more information, visit the event website.
August 2010
Pharmaceutical Tablet Technology
August 9 - 11, 2010
St. Charles, MO USA
Tablet press operators, tablet press maintenance technicians, granulation technicians, QC/QA personnel and supervisors with experience and/or backgrounds in chemistry, biology, engineering and pharmacy will benefit from attending and actively participating in discussions during this course. For more information, visit the event website.
Writing in the Regulated Environment When English Is Your Second Language
Aug. 19 & 20, 2010
King of Prussia, PA
Participation will be beneficial to those who work in a regulated environment and need to produce documents to support regulatory filings and/or product information. This course presents a comprehensive overview of the structure of American English to give non-native writers the tools they need to produce clear, complete, and comprehensive documents. Participants will learn about English within the context of the type of writing that industry requires. The course covers the structure of the language and how to control the individual components, as well as the choices writers have in delivering messages. For more information, visit the event website.
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
Aug. 23 – 25, 2010
King of Prussia, PA
This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment and whose roles and responsibilities require that they understand and apply cGMP Quality principles. This course is intended to give participants a thorough understanding of cGMP principles, as well as, tools that may be used in developing and managing current Good Manufacturing Practices. Pictures, flow diagrams, examples of actual procedures and warning letters are included in the presentation to demonstrate basic cGMP concepts. Participant interaction is desired and encouraged. For more information, visit the event website.
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
Aug. 26 & 27, 2010
King of Prussia, PA
This two-day course is designed for all persons who are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control Analytical Laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This course will provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations, Corrective and Preventive Actions. For more information, visit the event website.
September 2010
ExL Pharma 2nd Euro Lean Sigma and Kaizen for Life Sciences
September 9-10, 2010
Berlin, Germany
This Summit is specifically designed for C-Levels, Department Heads, Vice Presidents, Directors and Managers at pharmaceutical, biotechnology and medical device companies. For more information or to register, click here.
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
Sep. 8 – 10, 2010
Costa Mesa, CA
The course notes and interactive exercises address how to write effective correspondence and reports in support of a company’s activities. Participants will learn how to organize and deliver information for the intended audience. Attendees will also learn to write clear and readable documents, and how to revise and refine their own and others’ writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues. For more information, visit the event website.
2010 PDA/FDA Joint Regulatory Conference
September 13 - 15, 2010
Washington, D.C.
The PDA/FDA Joint Regulatory 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. Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance. You won’t find this level of direct information exchange with FDA at any other conference! PDA is also offering an exhibition during the conference. The PDA Training and Research Institute (PDA TRI) will host courses immediately following the conference (September 16-17, 2010) to complement what you learn at the meeting.
PAT Implementation Strategies for Pharmaceuticals & Biotech
Sep. 13-15, 2010
Philadelphia, PA
Turn PAT’s potential advantages into real-world benefits at IQPC’s Implementing PAT Summit taking place September 13 - 15 in Philadelphia, PA. Pharmaceutical manufacturing waste can be as high as 50%. It can be difficult to analyze and correct the causes of drug manufacturing failures. By implementing PAT your company has the potential to lower costs and improve quality. Attend this conference and learn:
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How to prove ROI of PAT initiatives
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Prevent costly rejection of batches
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Discover how to reduce production cycling time by increasing automation
For more information, visit the event website.
Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
Sep. 15 & 16, 2010
King of Prussia, PA
This course has been developed to provide a greater understanding of how financial decisions affect the daily operations of companies involved in the pharmaceutical, biotech and medical device sector. The content of this course gives each attendee a comprehensive introduction to business and finance. It covers the basics such as where cash comes from and how it flows through and leaves the business, the criteria required to make capital investment decisions, and how the business knows when it is successful in meeting strategic objectives. Real life business situations are introduced that directly reflect company specific performance and provide participants with an opportunity to apply new skills. For more information, visit the event website.
IBC BioProcess International™ Conference & Exhibition
Sep. 20 - 24, 2010
Providence, RI
IBC’s BioProcess International Conference & Exhibition has become the largest, most well respected forum focusing solely on technical, regulatory and strategic planning challenges in the manufacture of biotherapeutics. This event is truly THE place to gain the latest industry updates, make new contacts and initiate collaborations in biopharmaceutical production. Taking place on September 20-24, 2010 in Providence, Rhode Island, it is the one conference you need to attend this year if your goals are to:
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Streamline your processes by adopting new technologies or improving current manufacturing operations
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Hear what comes next after titer increase
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De-Bottleneck your downstream process
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Expedite your candidates through the CMC approval process
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Manage process changes in your post-approval products
Register today by calling 800.390.4078 or online at www.IBCLifeSciences.com/BPI.
5th Annual Manufacturing Execution Systems
September 21-22, 2010
San Diego, CA
Over 700 pharmaceutical, biotech and medical device executives have benefited from CBI’s Manufacturing Execution Systems Conference. Mark your calendar for the 5th Annual MES, which convenes manufacturing decision-makers from the pharmaceutical and biotech community. MES is necessary for process control, QA/QC, better yield, reduced reliance on paper batch records and FDA compliance. This conference covers the automation solutions, process control tools and manufacturing control systems for the process manufacturing needs of pharmaceutical, medical device and biotech companies. The conference presents industry case studies and vendor presentations, illustrating the industry’s state of sophistication for MES adoption and integration.
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Hear how to assess your current production processes and evaluate diverse MES implementation strategies
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Learn how to integrate your MES with existing ERP, EBR, LIM and DCS systems
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Attend pre-conference workshops on “Change Control Procedures during MES Implementation” or “The Role of QbD in MES”.
For more information, visit the event Web site.
Sep. 29 – Oct. 1, 2010
King of Prussia, PA
The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, cosmetics, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data, from pre-clinical studies, that will be incorporated into regulatory filings with the FDA and corresponding organizations overseas. This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes. For more information, visit the event website.
3rd International Symposium on Green Processing in the Pharmaceutical & Fine Chemical Industries
Sep. 30 – Oct. 1, 2010
Boston, MA
Registration is now open for the aforementioned symposium to be held at University of Massachusetts Boston Sept 30 - Oct 1. Confirmed Keynote Lecturers: Roger A. Sheldon, Professor Emeritus, Delft University of Technology and John C. Warner, President & CTO, Warner Babock Institute for Green Chemistry. Confirmed speakers represent Lonza, Pfizer, DSM, Syncore Laboratories, Inc,, Codexis, Mettler Toledo, Novasep, Howard University, William J. Clinton Foundation, McGill University, Northeastern University, University of Massachusetts Boston and many others. Posters from students and young faculty are encouraged. For more information, visit the event website.
European Pharma Maintenance Masters 2010
September 30 - October 1, 2010
Berlin, Germany
Without pharmaceutical maintenance procedures in place, product producers are taking the risk of equipment failures, causing key pieces of machinery to be withdrawn from use. In certain cases, this one piece of equipment may result in the closure of an entire production line. In this state, pharmaceutical maintenance and repair costs will be high, since it will mainly consist of recovering from catastrophic break downs. In order to prevent such incidents, manufacturers of pharmaceuticals are in need of a strategic approach to maintenance, OEE, Operational Excellence and change control management. The first annual "European Maintain Pharma Masters", held in Berlin, will discuss strategic approaches to the handling and management of pharmaceutical plants for engineering and maintenance Head Of´s. With international Top-speakers at a senior executive level, the European Pharma Maintenance Masters will establish a new approach in finding the right maintenance excellence strategy for pharmaceutical manufacturers worldwide. For more details, visit the event website.
October 2010
Tablets & Capsules - Development, Manufacture and Testing of Solid Oral Dosage Forms
October 4 - 6, 2010
Costa Mesa, CA
This two-and-a-half day course is designed for pharmaceutical R&D or manufacturing personnel who are in any way involved in the development, manufacture, testing, release and/or registration of solid oral dosage forms of small molecule pharmaceuticals.
Upon completion of this course, attendees will have a clear understanding of the technical/ scientific principles and regulatory requirements to be taken into consideration for preformulation, formulation and process development, manufacturing, and testing of solid oral dosage forms (tablets and capsules). Attendees will have gained the background knowledge necessary to effectively design and execute a development plan for tablets and capsules, including drug product registration. For more details, visit the event website.
October 4 - 5, 2010
Hyatt Regency - Boston, MA
LogiPharma 2010, now in its 9th year is a 2 day event for Pharmaceutical and Biotech companies that provides strategies and best practices for improving supply chains. This comprehensive event brings together executives from all aspects of the supply chain to discuss practical strategies for streamlining processes and cutting costs. Register now with code 10352XZ47 and receive 25% off your registration. Join your peers to tackle end-to-end challenges in your supply chain including:
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Increasing flexibility in your supply chain to reduce costs and improve agility
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Utilizing sales and marketing departments to adequately forecast production needs
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Ensuring security, compliance and visibility throughout the supply chain
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Understanding the effects of new legislation on your day to day operations
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Maintaining quality assurance while streamlining your temperature controlled distribution
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Using new technologies to reduce diversion and tampering along the supply chain
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Leveraging supply chain synergies across business units
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Applying lean production techniques to the pharmaceutical supply chain
For more information or to register, visit the event Website.
October 5 - 7, 2010
Paris Nord Villepinte
Driving innovation in Pharma technology
Hosted alongside CPhI, ICSE and BioPh, P-MEC (The Pharmaceutical Machinery and Equipment Convention) was first held in Madrid in 2005 and has since rapidly grown into a must-attend event for both sellers and buyers of pharmaceutical processing and manufacturing equipment.
P-MEC Europe 2010 is evolving! Now covering every aspect of Pharma and Biotech Equipment, Laboratory and Analytical techniques to Track & Trace technologies, P-MEC Europe 2010 offers a perfect synergy between its sister events ICSE (The International Contract Services Expo) and BioPh Europe (Bio Solutions for Pharma).For more information please contact the sales department at: +31 (0) 20 40 99 529 or send an email to: pmecsales@ubm.com.
October 5 - 7, 2010
Paris, France
CPhI Worldwide returns to Paris for 2010 when, with ICSE, PMEC and BioPh, the world s leading pharma services industry event will be staged at Paris-Nord Villepinte. For more details, visit the event website.
October 5 - 7, 2010
Paris Nord Villepinte
ICSE bringing outsourcing to CPhI
ICSE is the international stage for companies providing outsourcing services in Clinical trials, Contract research, Custom manufacturing, Biotechnology, IT, Analytical services, Packaging services and Logistics.
For over 10 years, ICSE has been connecting buyers and sellers in the market of (bio)pharmaceutical and pharma-related contract services. With a keen eye for new needs and new developments, each ICSE event is set up to fulfil its role as meeting place and intermediary as effectively as possible. For more information please contact the sales department at: +31 (0) 20 40 99 529 or send an email to: icsesales@ubm.com.
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
October 7 - 8, 2010
King of Prussia, PA
This two-day course is meant for those who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot, or commercial setting. Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing, and provides practical advice for attendees to troubleshoot and manage their aseptic operations. For more details, visit the event website.
2010 PDA Biennial Training Conference
October 11 - 15, 2010
Baltimore, MD USA
Join colleagues and connect with innovative leaders at the 2010 PDA Biennial Training Conference and take home the knowledge and skills you need to train your workforce. The conference is designed for anyone with training responsibilities in the bio/pharmaceutical industry and will provide the most current information needed to strengthen your training expertise. The format will include keynote speakers, concurrent sessions and workshops that allow you will have the opportunity to share ideas and interact with other training professionals. Complementing the conference are PDA Training and Research Institute (PDA TRI) training courses and an exhibition featuring vendors who provide excellent services in support of training efforts.
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
October 18 - 19, 2010
King of Prussia, PA
This two-day course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The course covers regulatory expectations regarding validation as contained in U.S. and international regulations. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention. This course will prepare attendees to plan and execute effective and compliant method validation plans. There will be an opportunity to apply what you have learned in a validation workshop. For more details, visit the event website.
PDA’s Universe of Pre-filled Syringes and Injection Devices
October 18 - 21, 2010
Las Vegas, NV
The 2010 PDA Universe of Pre-filled Syringes and Injection Devices brings together industry experts to share their experiences, new developments, regulatory considerations, challenges and industry trends in this exciting area. The topics will benefit those looking for a basic understanding of pre-filled syringes and injection devices as well as those looking for a more in-depth presentation of current challenges and developments. This is a must-attend event for all industry professionals involved in the development, manufacturing, or use of pre-filled syringes and injection devices. The PDA Training and Research Institute (PDA TRI) will host training courses October 20 and 21 to complement topics covered during this meeting.
6th Modern Drug Discovery and Development Summit (M3D)
October 20 - 22, 2010
San Francisco, CA
On October 20–22, Over 100 leading industrial and academic experts will present at the three-day 6th Modern Drug Discovery and Development Summit (M3D). The M3D summit will offer an in-depth examination of the challenges involved in the dynamic and ever-changing field of drug discovery and development. It will bring researchers, lab directors/managers, and industry executives the critical scientific, technology, and business coverage that they need. The M3D summit will include four tracks covering biological therapeutics research and development, biomarker discovery and development, cancer targets and therapeutics and advances in stem cell discovery and development, plus a half day plenary session featuring presentations from top executives from biotech and pharmaceutical companies. For more information, visit the event website.
PDA’s 5th Annual Global Conference on Pharmaceutical Microbiology
October 25 - 28, 2010
Washington, D.C.
The 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. The agenda includes discussions on topics such as objectionable microorganisms, investigations of microbial data deviations, manufacturing and product attributes impacting sterility assurance, new technologies and more! The PDA Training and Research Institute (PDA TRI) will host five courses on October 28 to complement topics presented at this conference.
November 2010
IBC Biopharmaceutical Manufacturing & Development Summit
November 1 - 3, 2010
Boston, MA
The only event with two in-depth tracks on enabling efficient facilities through single-use and other technologies, and on manufacturing excellence, to help you increase manufacturing agility and reduce process variability.
Register today by calling 800.390.4078 or online at www.IBCLifeSciences.com/BMD.
November 7 - 10, 2010
Orlando, Florida USA
How will we know “what’s next” in our industry? How do we prepare for it? Themed Discovering What’s Next: Reality, Retooling, Growth, this year’s ISPE 2010 Annual Meeting will help answer those critical questions and help prepare each of us for what is to come. For more details, visit the event website.
Sterilization Procedures: Technology, Equipment & Validation
November 10 - 11, 2010
King of Prussia, PA
This course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry. From the destruction of microbials, to the manufacture of sterile products, and validation of the sterilization procedures used, the course emphasizes the practical application of present-day basic scientific knowledge.
Upon completion of this course, participants will be able to understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different sterilization methods. Attendees will also be presented with the trends in regulatory thinking applied to aseptic processes, possible near-term future technological developments, sterilization methods, and microbial monitoring techniques. For more details, visit the event website.
The Drug Development Process – From Discovery to Commercialization
November 10 - 12, 2010
King of Prussia, PA
This course provides an understanding of the interrelated activities throughout the drug development cycle, and is designed for R&D, operations, marketing and sales management. This course serves as an introduction to the drug development process and will familiarize participants with the steps involved in developing a drug from discovery to commercialization. Included is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. In addition, this course covers sales planning and the commercialization decisions that affect the development of the drug. For more details, visit the event website.
November 14 - 18, 2010
New Orleans, Louisiana
AAPS will be offering a Full Conference registration fee in place of the AAPS member and non-member registration fees in order to accommodate members from the more than 40 co-sponsoring and supporting organizations. For more details, visit the event website.
PDA 2010 Pharmaceutical Freeze Drying Workshop
November 15 – 18, 2010
San Diego, CA
This PDA workshop will start with an overview on science and technology of freeze drying and will give an update on the latest technical developments. In the afternoon there will be three concurrent workshops on development, production and special challenges/freeze drying of potent and temperature-sensitive products. The concurrent workshops will have case study presentations and plenty of time to discuss current issues with industry experts, colleagues and presenters. Held in conjunction with the 2010 Pharmaceutical Freeze Drying Workshop is the PDA Training and Research Institute course, Fundamentals of Lyophilization, November 15-16, 2010.
IQPC Laboratory Informatics West Coast
November 15 - 17, 2010
San Diego, CA
IQPC’s conference on Laboratory Informatics West Coast s being organized for all people actively involved in the lab. The conference is targeted at decision makers, policy strategists, problem solvers, advisors, researchers, and consultants who utilize informatics in pharma, biotech, life science, agricultural, clinical, and academic settings.
Our previous Laboratory Informatics event focused largely on ELN in the pharmaceutical industry and, while attendees found the conference informative and helpful, they requested that we cover a wider range of topics this time around. Displaying the natural curiosity inherent to scientists and researchers, they also expressed interest in learning more about how informatics are being used in fields other than pharma. As a result, this November’s conference will address both a greater variety of topics and industries.
For more information, please visit the event Web site, www.labinformaticsforum.com.
Eastern Analytical Symposium and Exposition
November 15 - 18, 2010
Somerset, New Jersey
Eastern Analytical Symposium and Exposition (EAS) is the world's leading community for analytical chemists seeking the highest quality education and career development. Our wide variety of technical programs, globally recognized speakers, and large exhibition offer attendees highly applicable job training and an exceptional professional networking experience. At EAS, attendees improve their skills, validate research, interact with peers, experts, and vendors, achieve higher job performance and productivity, and enhance career opportunities. For more details, visit the event website.
November 18 - 19, 2010
King of Prussia, PA
This two-day course is designed for those who manage, audit, or oversee manufacturing of OTC drug products, and for cosmetic manufacturers with OTC drug products (no dosage) performing their operation under a drug cGMP environment.
This course gives the tools for risk-based implementation and continuous compliance with drug cGMPs for OTC drug product manufacturers, including cosmetic manufacturers that also produce OTC drug products. The course will also cover regulatory expectations as contained in U.S. and International guidelines. It will prepare attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps, and execute a plan to achieve compliance by initially addressing higher risk items within a reasonable time frame. For more details, visit the event website.
December 2010
PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies
December 1-3, 2010
Bethesda, MD
The PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop is being organized currently as a result of recent viral contamination events. This workshop is intended to encourage modernization in industry with respect to viral detection and control measures. Gaps in our current ability to detect, control and clear adventitious viruses; the availability of emerging technologies in areas where gaps exist; and CGMP expectations for adventitious virus detection and control, as well as consequences for noncompliance will be discussed.
December 1 - 3, 2010
Mumbia, India - Bombay Exhibition Center
Hosted alongside CPhI and ICSE, P- MEC (The Pharmaceutical Machinery and Equipment Convention) was first held in Madrid in 2005 and has since rapidly grown into a must-attend event for both sellers and buyers of pharmaceutical processing and manufacturing equipment. P-MEC India was launched in 2007.
P-MEC has proven to be an invaluable new opportunity for exhibitors to meet new and existing clients, to find and approach new markets and to stay abreast of new developments in pharmaceutical manufacturing. For more information please contact the sales department at: +31 (0) 20 40 99 529 or send an email to: pmecsales@ubm.com.
December 1 - 3, 2010
Costa Mesa, CA
The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, cosmetics, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data, from pre-clinical studies, that will be incorporated into regulatory filings with the FDA and corresponding organizations overseas. This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes. For more details, visit the event website.
Stability Programs for Product Shelf Life - From Development to Approval
December 6 - 7, 2010
Costa Mesa, CA
This course will be valuable to personnel in stability, research and development, regulatory affairs, manufacturing, quality assurance, and the quality control laboratory, who are involved in conducting, supervising, or managing stability testing. Among the topics to be discussed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and Standard Operating Procedures (SOPs), designing and validating stability indicating analytical test methods, establishing successful stability data management systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection. For more details, visit the event website.
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
December 6 - 8, 2010
King of Prussia, PA
This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment and whose roles and responsibilities require that they understand and apply cGMP Quality principles. This course is intended to give participants a thorough understanding of cGMP principles, as well as, tools that may be used in developing and managing current Good Manufacturing Practices. Pictures, flow diagrams, examples of actual procedures and warning letters are included in the presentation to demonstrate basic cGMP concepts. Participant interaction is desired and encouraged. For more details, visit the event website.
January 2011
February 2011
February 7-10, 2011
Charlotte, NC
Informex brings together serious buyers and sellers of chemicals, biologics, chemical technologies and related services. It is the global meeting place to efficiently showcase, as well as learn about, the capabilities of high-value, high-quality fine, specialty and custom chemical manufacturers, from pilot to commercial scale. No Matter What Your Industry, You'll Find the Next Big Idea at Informex.
For more information please visit: www.informex.com.
February 7-10, 2011
Orlando, FL
ARC's World Industry Forum focuses on challenges that will help you develop winning strategies. It provides the ideal environment for industry executives to collaborate, share ideas, and find new ways to attack their most pressing problems. The event includes sessions on the major issues facing our industry, with multiple tracks that enable executives to explore these topics from different perspectives. Owner/operators, solution providers, and technical experts will all benefit from this experience while simultaneously contributing to the community’s body of knowledge. Please join ARC and industry executives at this top event of its kind! February 7th-10th, 2011 at the Renaissance Orlando at SeaWorld Marriott.
For more information please visit: the event Website.
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