FDA Regulations Governing GCP, GLP and GMP

1. FDA Regulations Governing GCP, GLP and GMP www.grcts.com

2. FDA Regulations Governing GCP, GLP and GMP Description: It is important for the FDA-regulated industry to better understand applicable FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) for drugs, biologics and medical devices including in vitro diagnostics (IVDs). This webinar is intended to help the FDA-regulated industry get better familiar with the GLP, GCP and cGMP requirements from regulatory and compliance perspectives. www.grcts.com

3. FDA Regulations Governing GCP, GLP and GMP Good understanding and adequate implementation of the regulatory requirements under GLP, GCP and cGMP regulations are critical to make better, informed business and regulatory decision. Adequate awareness can greatly help firms save a significant amount of various business resources. In this presentation, the speaker will discuss FDA regulations including key provisions and requirements governing GCP, GLP and GMP applicable to drugs, biologics and medical devices including IVDs. www.grcts.com

4. FDA Regulations Governing GCP, GLP and GMP Areas To Be Covered in this Webinar: • Laws and Regulations • Definitions • Good Laboratory Practice (GLP): Regulation and Important Requirements • Good Clinical Practice (GCP): Regulation and Important Requirements • Regulations for Current Good Manufacturing Practice (CGMP) for Food, Drugs, Biologics and Medical Devices • FDA Guidance(s) and Standard(s) • Best Practices When Implementing GLP, GCP and GMP: Dos and Don’ts • Speaker’s PASS-IT Recommendations www.grcts.com

5. FDA Regulations Governing GCP, GLP and GMP Who will benefit: • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc. • Compliance Officers • Regulatory Affairs • Clinical Affairs • Quality Assurance • Laboratory Personnel • IT Professionals • R&D • Consultants • Contractors/Subcontractors • Other professionals interested in this topic www.grcts.com

6. FDA Regulations Governing GCP, GLP and GMP Instructor Profile: 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. www.grcts.com