FDA Compliance 2011 - 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.

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.