Firms operating in an FDA-regulated industry should be well-aware of and understand what laws and regulations apply to FDA-regulated products (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics).
This session by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will help you learn the laws and regulations governing food, drugs, biologics, cosmetics, combination products and medical devices including in vitro diagnostic medical devices (IVDs). David will share key statutory and regulatory requirements as set out in the laws and regulations and will provide an overview of recent changes and amendments to important FDA regulations. Domestic and foreign firms, who are involved in either directly or indirectly handling medical products (food, drugs, cosmetics, combination products, medical devices and IVDs) will become aware of the regulations that impact these products.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.