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FDA Compliance

FDA’s New Process Validation Guidance Explained at ISPE 2011

Session to cover updates, implications of new guidance

Published: Monday, February 7, 2011 - 13:38

(ISPE: Tampa, FL) -- Attendees of the International Society for Pharmaceutical Engineering’s (ISPE) 2011 Tampa Conference on Applying Solutions to Emerging Industry Challenges will have the chance to learn firsthand about the implications of the Food and Drug Administration’s (FDA) newly updated “Guideline on General Principles of Process Validation” as part of one the event’s educational sessions, “Pharmaceutical Inspections and Compliance - Current FDA Enforcement Trends.” FDA consumer safety officer Grace McNally will present the guidance and will explain how this guidance differs from the 1987 guidance it updates, as well as how the guidance will change pharmaceutical process validation in general.

“The new guidance from the FDA contains some significant changes to previous recommendations,” says Bob Best, ISPE president and CEO. “In fact, it seems like the new guidance practically redefines the entire concept of process validation, and will definitely change the way of thinking for many people in the industry. We’re very fortunate to have Grace McNally speak at our Tampa conference, since this will be the first chance the industry will get to discuss the new recommendations face to face with the FDA.”

In addition to McNally, the session will feature FDA speakers Brian Belz and Steven Wolfgang, and industry experts Sion Wyn, director of Conformity Ltd., and Swroop Sahota Ph.D., vice president of quality operations at Merck & Co. Inc. The two-day session will also cover dual FDA/industry presentations on the topics of enforcement, supply chain and vendors/CMOs, good manufacturing practice (GMP) quality systems, 21 CFR Part 11, management responsibility, current inspections, and continuous manufacturing.

Complete seminar agendas and training course outlines for the 2011 Tampa Conference are available on the ISPE website. To register for the conference, visit www.ISPE.org/2011TampaConference, or call ISPE member service at (813) 960-2105.


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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.