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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 :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- 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.