Monday, January 9, 2012

FDA Audit Preparation

Photograph of the Taxus drug-eluting stent, fr...
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The folks from Emergo Group have a very nice outline of how to think and approach FDA inspection readiness, before the FDA actually shows up at your door.

Preparation for an FDA Quality System Audit - from Emergo Group:
"In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP)."
'via Blog this'

You might also be interested in:
Surviving an FDA Inspection by SkillsPlus International Inc.

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