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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

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Is Kappa the Number One Reason Why Companies Are Getting 43s and Warning Letters?

Kappa, the complaints and NDRs are all measures of like effectiveness of a company's quality system and practices. So I guess one can postulate that if Kappa is the number one reason why companies are getting 43s and warning letters, then that might indicate they don't have a very effective quality system. And to that I have some suggestions, you know, for our company friends, as we'll get to further in our discussion,. But specifically how do you measure the effectiveness or what I call the efficacy of your Kappa system or of your QMS?

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