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FDA’s New Process Validation Guidance Explained at ISPE 2011

Session to cover updates, implications of new guidance

ISPE
Mon, 02/07/2011 - 13:38
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(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.

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