Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

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BioPharm International, BioPharm International-08-01-2002, Volume 15, Issue 8

by Massoud Lavian and Paul W. Allen, Clarkston Consulting Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs your company money, time, and reputation. Proactive managers understand the logic behind FDA regulations and prepare accordingly. This three-part survival guide to inspections (whether from FDA, a client, an investor, or a European agency) will sharpen your vision of your company?s regulatory compliance picture.