Author: Nigel J Smart PhD

Surviving FDA Inspectors

No matter how well prepared you may be for an FDA Preapproval inspection…when the moment comes, a lot of things can go wrong just because you didn’t pay much attention to human factors. Having an inspection of your processes and...

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Post FDA Inspection Activities

After the inspection is finished, you will probably find yourself with a lot of things to be corrected, either in the process, system, documents, or in relation to your cGMP compliance program.. Don’t let panic get hold of you,...

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