Duration: 60 Minutes


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In FDA-regulated industry, it is imperative that firms should be well aware of recent policy changes and understand what laws and regulations apply for FDA-regulated products on the US market (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics).

This seminar is intended to discuss FDA policy changes including changes for FDA inspection in 2018. This presentation is further intended to help industry better prepare for and manage an FDA inspection in a proactive and effective manner. The speaker will share his actionable tips and advice in view of FDA policy changes in 2018.

The speaker 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 what lessons we learn from FDA enforcement and inspection practices.

The speaker will share his PASS-IT recommendation/suggestions – dos and don’ts.


Areas Covered in the Session :

  • Laws and Regulations
  • Recent FDA Policy Changes
  • FDA Inspection Manuals
  • FDA Inspection Types and Depth of Inspection
  • How to Avoid Common Deficiencies
  • Actionable Inspection Preparation and Management
  • Communication with EQ Skills
  • Employee Training
  • Actual Case Studies
  • Speaker’s PASS-IT Suggestions/Recommendations-Dos and Don’ts
  • Conclusion

Who Should Attend:

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Everyone Interested in the FDA Inspections and Drug Manufacturing

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.