Enforcement, Litigation, and Compliance Conference

Dennis Gucciardo moderated a panel on "Medical Devices: Do I need to Open a CAPA?"

There is widespread disagreement in the industry about when to open a Corrective and Preventive Action (CAPA). When is it appropriate to open a CAPA, and what are the implications of doing so, or choosing not to? What are agency expectations should everything go into a CAPA? If not, how are non-CAPA activities managed, and where are they documented? What will the FDA expect to see during an inspection? What role have CAPAs played in medical device litigation?

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