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Auditing the Auditor

Global Medical Device Podcast powered by Greenlight Guru

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The Importance of Having a Lead Auditor

I was responsible largely for our internal audit. So we had two locations and I would travel to our other location and facilitate as the lead auditor of that internal audit too. We were also ISO certified so we hosted recertifications or valence audits. And so that was two branches of the FDA that would come in to audit us. It usually wound up being about 25 audits where I was responsible for managing the front room in front of the audit, or the inFront of the audit team to be able to produce.

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