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

Published on: 
BioPharm International, BioPharm International-10-01-2002, Volume 15, Issue 10

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.