FDA Good Laboratory Practice (GLP)



Understanding the regulatory requirements set out under good laboratory practice (GLP) regulations is important so that the GLP requirements can be adequately implemented, helping to streamline regulatory processes and to save a significant time and effort during the process.
This webinar is intended to help industry get better familiar with the GLP requirements from practical perspectives.
This 60-min presentation will provide great opportunities to get familiar with GLP regulatory and compliance requirements applicable to many industries (drugs, biologics/biosimilars, and medical devices including IVDs, etc.).
This webinar is a must for professionals who are involved in studies subject to GLP regulations including anyone interested in the topics from other industry.

Areas to be Covered:

Laws and Regulations
GLP Regulations
GLP Requirements
Compliance to GLP Regulations
FDA Guidance and Standards
Best Practices: Dos and Don’ts
Speaker’s Recommendation and Suggestions on PASS-IT Solutions

Who will Benefit:

Regulatory Affairs
Compliance Officers
Complainant Managers
Managers (RA, QA/QC, CA)
Contractors and Subcontractors
Anyone interested in the topic

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.


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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