Paul W. Allen

Articles

When an FDA inspection is imminent, it pays to have a plan. Start by getting your paper 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.

Conducting the Audit - Ready or Not, Here They Come

You survived the FDA inspection. Now what? FDA always finishes the inspection by leaving you with a list of its observations. Part 3 concludes the survival guide series by describing the steps every company should take after the inspectors leave ? from developing a corrective action plan to writing a detailed response document.

Responding to Observations

by  Massoud Lavian and Paul W. Allen, Clarkston Consulting

Survival Guide to FDA Inspections: Part 3, Responding to Observations

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.

Author | Paul W. Allen