FDA's Grace McNally to Present at ISPE 2011 Tampa Conference

Attendees of ISPE’s 2011 Tampa Conference on Applying Solutions to Emerging Industry Challenges will have the chance to learn first-hand about the implications of the FDA’s 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,” said 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 & Company, Inc. The two-day session will also cover dual FDA/Industry presentations on the topics of enforcement, supply chain and vendors/CMOs, GMP quality systems, 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 Web site. To register for the conference, visit www.ISPE.org/2011TampaConference, or call ISPE Member Service at 813-960-2105.