Helen Winkle, Director of FDA's CDER's Office of Pharmaceutical Science, discusses QbD efforts within three different divisions of FDA: Office of New Drug Quality, Office of Biotechnology Products and Office of Generic Drugs. Ms. Winkle spoke at a Life Sciences panel discussion at the Emerson Users Exchange in Orlando in September, 2009. For more information, visit www.PharmaManufacturing.com.
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