GCP-GLP-GMP : Comparison and Understanding of FDA's 3 Major Regulations
In this webinar you will learn Regulations and Requirements for Good Clinical Practice, To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP
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For manufacturers for drugs, biologics, biosimilars, generics, and medical devices, firms are subject to various statutory and regulatory requirements under FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP.
Why should you Attend:
This webinar is intended to help FDA-regulated industry and professionals get better aware of and familiar with the GLP, GCP and cGMP requirements from practical, actionable perspectives. This webinar will help firms implement and achieve compliance with the FDA regulations with improved awareness.
Areas Covered in the Session:
Who Will Benefit:
- Laws and Regulations
- FDA Guidance and Definitions
- Good Laboratory Practice Regulations and Requirements
- Regulations and Requirements for Good Clinical Practice
- Regulations for Current Good Manufacturing Practice for Food, Drugs, Biologics and Medical Devices
- Common Mistakes and How to Avoid Them
- FDA Enforcement Cases
- Best Practices: Dos and Don'ts
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Anyone Interested in the FDA Drug Review and Approval Processes
Dr. David Lim , Ph.D., RAC, ASQ-CQA.is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker,He 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 has contributed 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 at the Regulatory Doctor.