In FDA-regulated industries, it is imperative that firms should be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is important to recognize policy changes and risk-based, strategic regulatory and compliance approaches (best practices) under the new administration.
Join this session with expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQ, who will discuss FDA’s policy changes, risk-based regulatory and compliance approaches under new administration for 2018 and beyond. This session will help youbetter prepare for and manage risk-based FDA inspection preparation and management, in a proactive and effective manner. David will share his actionable tips and advice in view of recent FDA policy changes and enforcement actions. He will help you improve your awareness and knowledge of FDA enforcement and inspection policy and risk-based approaches under the new administration.
David will discuss practical, actionable, and sustainable guidance on how to prepare for a risk-based FDA inspection and how to manage the FDA inspection process, including the dos and don’ts before, during, and after the inspection. With this session, you will become familiar with the lessons learnt from the FDA enforcement and inspection practices. David will also share his recommendations/suggestions for the dos and don’ts of PASS-IT.
This session will give an overview of:
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.