Massoud Lavian

Articles

Conducting the Audit - Ready or Not, Here They Come

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.

Responding to Observations

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.

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

by Massoud Lavian and Paul W. Allen, Clarkston Consulting

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

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.