This conference by expert speaker Dr. David Lim will cover FDA inspection practices and the most common deficiencies for the medical device and pharmaceutical industries.This training session will help you prepare for and manage an FDA inspection in a proactive and effective manner. Dr. Lim will focus on the top 20 common deficiencies based on his analysis of 483s issued for the past several years.
You will get actionable, practical and sustainable guidelines on how you can prepare to sustain an FDA inspection effectively and how you can manage a FDA inspection process, including dos and don’ts during and after the inspection. As a participant, you will be able to familiarize yourself with FDA inspection practices derived from deficiencies observed during the past seven years. In addition, Dr. Lim will share his valuable PASS-IT recommendations and suggestions with you.
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.