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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

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Do What You Say You're Going to Do in Your Procedures

FDA citation from FDA is sounds like the company had a procedure to define that anyone in that company who identified an issue could surface or escalate that matter to a cap. I think you need to have a very, I'll say a culture of quality that encourages people to communicate when there are issues. This is an example I see so many companies where employees don't know what is in their own.

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