FDA Warning Letter Closeout Program
| Date: | 12-Jun-12 to 12-Jun-12 |
| Location: | OnlineWebinar / California / United States |
| Category: | Education |
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.
FDA's warning letter program has changed substantially and more warning letters will be issued - and faster! In the past, firms that received a warning letter from FDA were subject to unending scrutiny, speculation and financial challenge. But now warning letter recipients will have the chance to prove they are back in compliance. , FDA will provide a manner for a firm to demonstrate that it has complied with the terms of an enforcement action. The warning letter closeout program has begun as of September 2009. All firms who receive a warning letter will have the opportunity to obtain a "closeout" letter from FDA. Firms that fail to obtain a closeout letter will be clearly identified as still being under FDA scrutiny.
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.
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.
FDA's warning letter program has changed substantially and more warning letters will be issued - and faster! In the past, firms that received a warning letter from FDA were subject to unending scrutiny, speculation and financial challenge. But now warning letter recipients will have the chance to prove they are back in compliance. , FDA will provide a manner for a firm to demonstrate that it has complied with the terms of an enforcement action. The warning letter closeout program has begun as of September 2009. All firms who receive a warning letter will have the opportunity to obtain a "closeout" letter from FDA. Firms that fail to obtain a closeout letter will be clearly identified as still being under FDA scrutiny.
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.
Visitors
VP of Quality
Director of Quality
CEO, COO, President and other operating executives
Board of Directors
Quality managers and personnel
Internal auditors
Consultants
Director of Quality
CEO, COO, President and other operating executives
Board of Directors
Quality managers and personnel
Internal auditors
Consultants
Exhibitors
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.
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.
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