Some posts just don't age well (i.e., broken links below). Therefore, you might also be interested in:
FDA- Guide to Inspections of Quality Systems, August 1999
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Don't be caught flat-footed, be ready for the FDA. "Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...," says Chris Scholl Consulting Associates. On their site, they offer a free checklist, "21 CFR 820 Audit Checklist." If you don't know where or how to start, they suggest a couple of things to think about, "Are You Ready for the FDA?"
Additional QSR resources:
Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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