Outsourcing introduces considerable complexity into ensuring compliance with good manufacturing practices. This article offers FDA guidance for how to ensure compliance in the outsourcing environment.
Marlene Garcia Swider
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Marlene Garcia Swider is a regulatory project manager in the division of gastroenterology products at CDER, FDA
Articles by Marlene Garcia Swider
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FDA's Recommendations to Industry Regarding OutsourcingApril 2nd 2009
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