Survival Guide to FDA Inspections: Part 2, Conducting the Audit ? Ready or Not, Here They Come

Lavian,Massoud;Allen,Paul;

Publication

Article

October 15, 2002

BioPharm International

BioPharm International-10-01-2002

Volume15

Issue 10

Survival Guide to FDA Inspections: Part 2, Conducting the Audit ? Ready or Not, Here They Come

Author(s):

Massoud Lavian,Paul W. Allen

by Massoud Lavian and Paul W. Allen, Clarkston Consulting When an FDA inspection is imminent, it pays to have a plan. Start by getting your papers in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don't forget to take notes.

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