FDA Good Laboratory Practices (GLP) Regulations

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.

In this 60-min presentation, seminar speaker will guide you through the details of the necessary elements in the design control systems including, DHF, DHR, and DMR.

Areas Covered in the Session :

• Laws and Regulations
• Definitions
• 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 Should Attend:

• Research and Development Departments
• Quality Departments
• Regulatory Affairs Departments
• Compliance Officers Departments
• CEOs
• VPs
• Attorneys
• Complainant Managers
• Managers (RA, QA/QC, CA)
• Consultants
• Contractors and Subcontractors
• Anyone interested in the topic

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.