In FDA-regulated industries, firms must comply with a range of laws and regulations that apply to medical and other products such as food, drugs, biologics, cosmetics and medical devices, including those for in vitro diagnostics. The FDA’s Office of Regulatory Affairs (ORA) handles inspections to enforce these regulations, and if ORA investigators find violations, they list their observations on the FDA Form 483.
Join this session with expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, who will discuss FDA inspection practices and help you better prepare for and manage an FDA inspection. David will show you how to take a proactive and effective approach, including do’s and don’ts for before, during and after the inspection. David will also share his analysis of Form 483s and FDA warning letters issued for the past several years.
The session will provide you with key lessons learned from actual FDA enforcement and inspection practices. It will also provide you with an opportunity to get familiar with FDA enforcement actions and the agency’s inspection process. David will also share his PASS-IT recommendation/suggestions, which will help you put these crucial do’s and don’ts into practice.
This session will cover:
Who Should Attend
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.