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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

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Does Your CAPA Need a CAPA?

The number one reason why FDA issues 43 observations and warning letter is because of CAPA's. Many companies that I were with, they either come up with a solution that doesn't in fact solve a problem, or they come up with another solution that solves that problem. So it's that whole verification validation just like we do with medical devices, we're applying the same regulatory system to the CAPA system. And then the third thing that the regulation specifically says is investing in non conformities of the quality system. This is, you know, the sort of the title of today's discussion does your CAPA need a CAPA, right? It obviously doesn't work.

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