FDA Warning Letter Close-Out Program

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, May 06, 2014
60 Minutes
Product Description

Insights On FDA’s Warning Letter Close-Out Program

FDA notifies the firm in the form of a Warning Letter when the Agency finds that a firm has significantly violated FDA regulations (current Good Manufacturing Practice, cGMP).  The Warning Letter identifies the firm’s violations including, but not limited to, poor and inadequate manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the firm to inform FDA of its plans for correction.

As part of FDA’s enforcement initiatives, FDA implemented a Warning Letter “Close-Out” Program, which applies to Warning Letters issued on or after September 1, 2009.

According to the Close-Out Program, FDA may issue a Warning Letter "Close-Out Letter" once the FDA has completed an evaluation of firm’s actions undertaken in response to a Warning Letter.

In this audio session, Dr. David Lim, Ph.D., RAC, ASQ-CQA will discuss about FDA’s Warning Letter Close-Out Program, including the thirty-two close-out cases. He will talk about practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection. In particular, David will present the FDA’s Warning Letter Close-Out Program and actions based on 32 recent cases.

This session will provide great opportunities to become familiar with the FDA inspection practices, warning letter close-out program, and the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past seven years.

The speaker will also share his PASS-IT recommendation/suggestions.  

Areas To Be Covered in this Seminar:

  • Applicable Laws and Regulations
  • FDA Enforcement and Compliance Manuals
  • FDA Inspection Guides
  • Hosting an FDA Inspection
  • Factors/Matters Leading to Warning Letters
  • FDA Forms 482 and 483
  • Establishment Inspection Reports (EIRs)
  • The Common Deficiencies during FDA Inspections for Firms (Food, Devices, and Pharmaceuticals)
  • How to Communicate Before, During and After FDA Inspection: Dos and Don’ts
  • What to Discuss During Close Out Meeting at the End of an Inspection
  • Responding to 483s, if issued
  • Dealing with Warning Letters
  • Consequences of Inadequate Corrections and Repetitive Violations
  • FDA’s Warning Letter “Close-Out” Program
  • Warning Letter Close-Out Timelines based on 32 Cases
  • When FDA Issues a Close-Out Letter
  • When FDA Doesn’t Issue a Close-Out Letter
  • Good Practices
  • Speaker’s PASS-IT Suggestions/Recommendations
  • Conclusion

Get answers to your questions in a Q&A session by the speaker to help you with the doubts and queries you may have.

Who should attend:

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA inspection Process

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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