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Process Validation is the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Grace McNally, FDA, will discuss and review the goals of the 2011 Final Guidance on Process Validation, the various stages of the lifecycle approach and key recommendations, cGMPs and Process Validation (PV) for drug manufacturing, legacy products and process, terminology, as well as the major concerns about the 2008 Draft and response.

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