BioPharm International-11-15-2003

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.

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

Review

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.

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.

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.

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.