FDA's Grace McNally to Present New Process Validation Guidance at Tampa Conference

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ISPE NEWS
FOR IMMEDIATE RELEASE

For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org

FDA Speaker Grace McNally to Present on USFDA’s
New Process Validation Guidance at ISPE 2011 Tampa Conference

—Session to cover updates, implications of new guidance—

(TAMPA, FLORIDA, USA, 2 February 2011) – 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 & Co., 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 Services at telephone +1-813-960-2105. For press passes to attend this event, contact Danielle Hould, ISPE Communications Manager, by telephone at +1-813-960-2105 or via email at dhould@ispe.org.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 24,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their 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 opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.

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