FDA Warning Letter Closeout Program --FDA Compliance Training (FDA Compliance Train)
|Event Date/Time: Nov 18, 2010||End Date/Time: Nov 18, 2010|
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.
Attend this Webinar to know everything about warning letters, warning signs, issuance, companyâ€™s response and how to rectify the FDA warning letter close out mistakes.
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.