Are You Prepared for the FDA?

The FDA Inspection Handbook is a comprehensive review of the entire investigation process, not only from the company's side, but from the investigators' side as well.  It covers the scope, consequences and actions for all types of FDA inspections.  The Inspection Handbook gives you an in-depth look at the actual investigation, the documentation needed, the affidavits, how to deal with the aftermath, and links to regulations, key documents, statutes and limitations.  You'll know how to prepare and what to expect.

With the FDA Inspection Handbook, you can:

• Have a complete overview of the FDA authority in dealing with inspections, how they prepare, what they will be looking for, and the trends the professionals have been seeing
• Have a comprehensive understanding of what the FDA has the right to request, the documents you'll need, collection of samples and affidavits from employees
• Understand a 483 - the timing, your response and what to expect afterward
• Consult specific sections for clinical trials and medical device inspections
• Additional links to support documentation and regulations

To order a copy, click here.