Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP).
It is important for the industry to accurately understand the requirements under Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).
This seminar is intended to help industry get better familiar with the GLP, GCP and cGMP requirements from regulatory, practical and compliance perspectives.
The speaker will walk you through regulatory and compliance requirements governing GLP, cGMP and GCP.
Areas Covered in the Session :
- Applicable Laws and Regulations
- FDA Guidance and Standards
- Major Misconception
- Overview of each regulation – GCP, GLP, GMP
- How each regulation is the same
- How each regulation differs
- Regulations and Requirements for Good Laboratory Practice
- Regulations and Requirements for Good Clinical Practice
- Regulations for Current Good Manufacturing Practice
- Speaker’s PASS-IT Recommendations: Best Practices
Who Should Attend:
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Research & Development
- Lab Personnel
- Anyone who require a general understanding of the FDA’s 3 major regulations
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.