In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpose, and how to best implement it. Specifically, the following questions are addressed:

• Could you please briefly highlight the reasons FDA issues 483 observations and warning letters?
• What is a CAPA and when should it be used?
• What are the most common reasons for 483s and warning letters involving a CAPA?
• How do you know if your CAPA is doing what it’s supposed to do?
• Is industry taking the wrong approach with a CAPA? Is there a better way we could be looking at this issue?
• How are CAPAs related to other aspects of the QMS, such as risk, post-market surveillance, or complaint handling?
• Do you have examples that might help illustrate what we’ve discussed?
• What else is important and/or what are the most important takeaways?

Listen to this discussion and see if you have a better understanding of CAPAs. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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