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FDA Compliance

21 CFR Part 11 Course at ISPE 2010 Philadelphia Training Event

Course features latest information on the status of FDA’s current reexamination

Published: Tuesday, November 2, 2010 - 09:49

(ISPE, Tampa, FL) -- ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, will offer seven training courses, including a session focused on complying with 21 CFR Part 11, at its 2010 ISPE Philadelphia Classroom Training. The event will take place Dec.6–9 at the Hilton Philadelphia Airport in Philadelphia.

As a member-based organization, ISPE draws from the expertise of its members to develop training courses that address industry demands and provide in-depth knowledge on a specific topic. Many courses use case studies, team exercises, and ISPE guidance documents to immediately apply the learning objectives to real-life situations within their own organizations.

One of the event highlights will be the intermediate-level course, “Complying with Part 11—Risk Management: Applying the GAMP Good Practice Guide: Electronic Records and Signatures Principles.” Led by Sion Wyn, acknowledged computer systems validation expert and member of the U.S. FDA’s reexamination team, the course will feature up-to-the-minute information about the FDA’s current reexamination of the 21 CFR Part 11 and the European regulatory expectations, as reflected in the draft revised Annex 11. Participants will learn how to implement a risk management approach to ensure compliance of regulated electronic records and signatures through application of appropriate controls.

Other courses will focus on sustainability within HVAC, including HEPA filter theory; regulatory philosophy in sterile drug manufacturing facilities; and differentiating between regulatory requirements and regulatory myths relative to pharmaceutical water distribution and storage systems. Additional courses include practical application of GAMP5 and oral solid dosage forms. ISPE partnered with the ISPE Delaware Valley Chapter to select the courses for 2010 Philadelphia Classroom Training.

In addition to Wyn, recognized industry experts Dave DiProspero, Gary V. Zoccolante, Norman Goldschmidt, and Diana Knittel-Pace will be on hand to share their knowledge and experience as they lead the training discussions.

Some courses will offer CEUs with content related to the Certified Pharmaceutical Industry Professional (CPIP) technical knowledge and competency elements.

Full course descriptions, instructor bios, and registration information can be found at www.ispe.org/2010PhiladelphiaTraining.


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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.