Dr. David Lim’s Audio Conference Presentation on FDA Warning Letter Close-Out Program

FDA Warning Letter Close-Out Program
Speaker: Dr. David Lim, Ph.D., RAC, ASQ-CQA
Date: Tuesday, May 06, 2014
Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT
Length: 60 minutes
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 opportunìties 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. Read more

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
  • And More
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About Our Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. Read More
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FDA Warning Letter Close-Out Program
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