FDA Warning Letter Closeout Program --FDA Compliance Training (FDA Compliance Train)

Venue: OnlineEvent

Location: Palo Alto, California, United States

Event Date/Time: Nov 18, 2010 End Date/Time: Nov 18, 2010
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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.

Attend this Webinar to know everything about warning letters, warning signs, issuance, company’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.


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