In FDA-regulated industries, firms must understand and comply with the laws and regulations that apply to FDA-regulated medical and other products such as food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics. The FDA conducts investigations to enforce these regulations. Are you ready to tap into the opportunities and learn the lessons from FDA enforcement and inspection practices to prepare for 2018?
This session by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will discuss the FDA inspection practices to help you better prepare for and manage FDA inspections in a proactive and effective manner in 2018. You will learn actionable tips and get advice in view of the recent FDA policy changes. David will discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection. He will show you how to manage the FDA inspection process, including dos and don’ts before, during and after the inspection.
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.