Duration: 60 Minutes


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This seminar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.

We will also discuss 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.

This presentation will provide great opportunities to become familiar with the FDA inspection practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years. The speaker will share his PASS-IT recommendation/suggestions.

Areas Covered in the Session :

  • Applicable Laws and Regulation
  • FDA Manuals and Inspection Guides
  • Hosting an FDA Inspection
  • Field Management Directives
  • Inspection Types and Categories
  • Inspection Classification
  • FDA Forms 482 and 483
  • Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
  • How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
  • What/How to Prepare for and Manage an FDA Inspection
  • How to Communicate Before, During and After inspection: Dos and Don’ts
  • Common Mistakes and How to Prevent Them
  • How to Most Effectively Use Close Out Meeting
  • Responding to 483s, If Issued
  • How to Communicate with Emotional Intelligence
  • Employee Training
  • Actual FDA Inspection Case Studies (Reports)
  • Speaker’s PASS-IT Suggestions/Recommendations
  • Conclusion

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Departments
  • Manufacturing Departments
  • Regulatory Affairs Departments
  • R&D Departments
  • Clinical Affairs Departments
  • Senior Management
  • Consultants
  • Contractors
  • Compliance Officers
  • Anyone Interested in the FDA Inspection

Course Director: DR. DAVID LIM ‎

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim 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. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.