What Needs to Be Done During An Fda Inspection?

David Lim

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This presentation is intended to help both medical device and pharmaceutical industry get familiar with the “Best Practices” for what to do during an FDA inspection so that a firm can adequately prepare for and act during the FDA inspection.

Course Objective

This presentation discusses practical, actionable, and sustainable guidance on how to actionably engage in and communicate including Dos and Don’ts, in particular, during the inspection.   

This presentation will provide great opportunities to become familiar with the best practices for what to do during the FDA inspection.

The speaker will share his practical perspectives for you to consider and greatly improve your process of hosting an FDA inspection.

Course Outline

  • Applicable Laws and Regulations
  • FDA Guides and Manuals
  • FDA Inspection Logistics
  • Inspection Types, Categories and Classification
  • FDA Forms 482, 483 and EIRs
  • FDA Inspection Preparation and Management
  • Effective Communication During an FDA Inspection: Dos and Don’ts
  • Close Out Meeting
  • Responding to 483s, If Issued
  • Emotional Intelligence-based Approaches
  • Common Mistakes and How to Avoid Them
  • Best Practices to Prevent Common Mistakes in 483s
  • Best Practices for Achieving Compliance and Staying Compliant
  • PASS-IT Suggestions and Recommendations

Target Audience

  • Medical Device Quality and Compliance Professionals
  • Pharmaceutical Compliance Professionals
  • Quality
  • Regulatory Affairs
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA inspection Process (Pharmaceuticals)

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: David Lim,

Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, www.RegulatoryDoctor.com, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides Practical, Actionable and Sustainable/strategic Solutions in an Integrated, Thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters. Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). In addition, Dr. Lim has completed two years in law school. Dr. Lim is an auditor, regulatory coach, mentor, consultant and instructor for global matters pertaining to regulatory affairs, quality, clinical affairs and compliance.

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