FDA Warning Letter Closeout Program - Webinar by ComplianceOnline

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.

Why Should You Attend:

FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. Part of the "new FDA" is the increased issuance of warning letters and the creation of a warning letter "closeout", which regulated firms can use to your advantage.

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
• Consultants