This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.
Areas Covered in the seminar :
- Outline of FDA enforcement and compliance scheme.
- FDA inspection process.
- Lead up to a warning letter - warning signs.
- Warning letter issuance.
- Company response to FDA warning letters.
- What to avoid when dealing with FDA warning letters.
- Correcting FDA warning letter closeout mistakes.
Who will benefit :
This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers who have received, expect or fear an FDA-483 or Warning Letter. The staff members who will benefit include:
- VP of Quality
- Director of Quality
- CEO, COO, President and other operating executives
- Board of Directors
- Quality managers and personnel
- Internal auditors