BioPharm International Supplements, November 2003

Survival Guide to FDA Inspections

To Prepare or Not To Prepare - There is No Question

By Paul W. Allen , Massoud Lavian

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.

Conducting the Audit - Ready or Not, Here They Come

By Paul W. Allen , Massoud Lavian

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

By Paul W. Allen , Massoud Lavian

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.

Suggested reading

Dispute Resolution

Resolving Scientific and Technical Disputes

By Ronald F. Tetzlaff

Resolving disputes with FDA over scientific and technical issues demands familiarity with existing practices and procedures, as well as understanding recent and ongoing changes to how FDA handles disputes.

Review of FDA Dispute Resolution Practices and Procedures

By Ronald F. Tetzlaff

Review

21 CFR Part 11

Information Age Audits

By Joseph F. Noferi, Esq. , Daniel E. Worden , Edward R. Arling

Understanding the reach of 21 CFR Part 11 is the first step to assessing its impact. To protect your company, you need integrated quality audit solutions to evaluate the underlying validation of your electronic data.

FDA Inspections: Is Your Organization 21 CFR Part 11 Compliant?

By Larry Nold

Decoding what FDA means by “narrow interpretation” and “enforcement discretion” goes a long way toward helping you understand the FDA’s latest guidance on 21 CFR Part 11 and making sure your organization is compliant before an inspection.