ComplianceOnline

FDA Warning Letter Closeout Program

Instructor: Alfonso Fuller
Product ID: 701521
Training Level: Advanced
  • Duration: 60 Min

recorded version

$229.00
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2014

Training CD

$399.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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.

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
  • Consultants

Instructor Profile:

Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Computer System Validation - Reduce Costs and Avoid 483s

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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