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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

CHAPTER

Is It a Kappa Required?

The key thing for folks you know regardless of what your answer is, explain and justify and support your answer with corroborative evidence. No documentation exists explaining why a Kappa was not initiated. This is the regulatory equivalent of one of the most common reasons why regulatory submissions 510 K de novo PMAs are rejected because a section is omitted. How do we measure the effectiveness or what I call the efficacy of our Kappa system? We need more regulation that doesn't focus on intent but just the words "Kappa" John: What's an important part of this QMS discussion today involves a portion of the quality management system. And then we can wrap it up in our discussion about how to make sure

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