FDA Warning Letter Closeout Program
Tuesday, June 12, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
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
For Registration :
When & Where
At ComplianceOnline, we are focused on :
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- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.