Preparing for FDA BIMO Inspection and Management

Recently, FDA inspection scope and policy have been changed and updated. This webinar is intended to help you get familiar with FDA inspection process, in particular, Bioresearch Monitoring (BIMO) so that firms can better prepare for and manage a BIMO inspection with awareness in a proactive and effective manner.

This webinar will 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 webinar will provide great opportunities to become familiar with the FDA BIMO inspection.

The speaker will share his new and useful information to greatly improve your awareness and to consider for implementation while preparing for and managing your FDA inspection matters. This 60-min presentation is a must for those working in FDA-regulated industries (drugs, biologics/biosimilars, medical devices including IVDs/LDTs and cosmetics, etc.).

Areas Covered in the Session :

  • Laws and Regulations
  • FDA Manuals
  • Inspection Guides
  • Hosting an FDA Inspection
  • Field Management Directives
  • Inspection Types and Categories
  • Inspection Classification
  • FDA Forms 482 and 483
  • Establishment Inspection Reports (EIRs)
  • What/How to Prepare for and Manage an FDA Inspection
  • How to Communicate Before, During and After inspection: Dos and Don’ts
  • Inspection Preparation Procedures
  • Close Out Meeting
  • Responding to 483s, If Issued
  • How to Communicate with Emotional Intelligence
  • Employee Training
  • Actual Case Studies
  • Conclusion
Who Will Benefit:

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


Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( 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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance