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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

CHAPTER

Kappa - The Number One Reason FDA Issued 43 Observations and Warning Letters

Kappa is an acronym for corrective action and preventive action. FDA has issued 43 observations and one letters over the last five years. Kappa's obviously the topic of today's conversation. Number two, customer companies. Number three, purchasing controls under the general topic of supplier management. Number four, medical device reporting or MDR procedures, and finally, assess validation.

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