Preparing for FDA BIMO Inspection and Management

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Description:

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 to be Covered:

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 Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
R&D
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 (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.

This product is currently out of stock and unavailable.

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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