Management of an Effective CAPA

Why do so many companies struggle internally with their CAPA (corrective/preventive action) program? As with other regulations, US FDA Title 21, CFR Parts 211.160, 211.192, 810.100 have good definitions, but it’s up to companies to apply the requirements and then put their own approach and rationale together for a compliant CAPA program.

Here's the big question: how do we interpret the regulation, develop the procedure, and then get our internal teams to respond in a timely manner?

In this webinar, Tim Fischer explores the foundation and development of a good CAPA program, including what critical quality oversight and management review should entail.