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Event: FDA-ISPE Collaboration: Pharmaceutical Quality Systems

Event to focus on pharmaceutical quality systems.

Published: Friday, May 7, 2010 - 09:41

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 24,000 pharmaceutical science and manufacturing professionals, and the U.S. Food and Drug Administration (FDA) are co-sponsoring FDA-ISPE Collaboration: Pharmaceutical Quality Systems, a highly-interactive two-day session to take place on June 9–10 at ISPE’s 2010 Washington Conference—"Applying Risk-based Approaches," being held at the JW Marriott in Washington, D.C., June 7–10.

As part of FDA’s pharmaceutical current Good Manufacturing Practices (cGMP) for the 21st Century Initiative, the FDA, along with industry leaders and regulatory agencies from other countries, have identified key components of a modern pharmaceutical quality system in ICH Q10, the International Conference on Harmonization (ICH) guidelines concerning pharmaceutical development and quality risk management. Co-sponsored by the FDA, this two-day seminar will provide a special “town hall” forum for the exchange of information between the FDA and the industry, and will focus on pharmaceutical quality systems and the implementation of elements that enhance its effectiveness.

“Regulators from around the world have always been very generous in sharing their knowledge and expertise with ISPE members and our conference attendees,” says ISPE president and CEO, Robert P. Best. “We are very privileged to again have their participation in our upcoming event in Washington.”

The ISPE 2010 Washington Conference brings together all levels of pharmaceutical industry professionals to network and benefit from a variety of seminars and training. The Washington Conference features include barrier, product quality lifecycle implementation/quality by design (PQLI/QbD), commissioning and qualification (C&Q), critical utilities, process validation, cleaning, biotechnology, Good Automated Manufacturing Practices (GAMP) guides, good practice guides (GPG), sustainability, and biologics manufacturing.

Several ISPE guidance documents will be launched or discussed at the Washington Conference including “GAMP Good Practice Guide: Manufacturing Execution Systems,” “GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems,” and the “ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC).”

A MedImmune plant tour of their Therapeutic Protein facility is also featured as part of the Trends in Biologics Manufacturing session.

Speaker information, along with seminar agendas and training course outlines for the four-day event has been posted to the ISPE web site and include the following:

June 7–8

  • Barrier Isolation Technology Forum: Innovation, Updates, and New Case Studies
  • PQLI: Case Studies in QbD for Biotechnology and Small Molecule Product Realization
  • Science and Risk-Based Commissioning and Qualification: Transitioning and Transforming  
  • Critical Utilities: Best Practices in Managing Risk and Cost 


June 8

  • GAMP Good Practice Guide: Manufacturing Execution Systems (Guide Launch)
  • Practical Answers to Common HVAC Questions – An introduction to the HVAC Good Practice Guide  (Complimentary session to all ISPE members and conference attendees)


June 9–10

  • Science and Risk-based Validation: Practical Approaches Across Projects by Breaking Down Implementation Silos
  • FDA-ISPE Collaboration: Pharmaceutical Quality Systems
  • GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems (NA Guide Launch)
  • Sustainability: Best Practice Case Studies and Legislation Impact  
  • Trends in Biologics Manufacturing (with MedImmune Tour of Therapeutic Protein facility)


Training courses will also be offered including:

June 7–8

  • Process Validation in Biotechnology Manufacturing - Advanced
  • Cleaning Validation Principles - Intermediate


In addition, the event will include tabletop exhibits from more than 60 of the industry’s top suppliers of pharmaceutical manufacturing equipment, and networking opportunities for pharmaceutical industry professionals. ISPE’s Career Solutions Center will also be featured at the event.

For complete seminar information, and to register for the conference, visit www.ISPE.org/2010washingtonconference.


About The Author

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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.