Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k) and PMAs in various forums and meetings. Recently, Dr. Lim developed 510(k) and PMA templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA's transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider at FDA news.

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Speaker: Dr. David Lim
Duration: 60 Minutes
Product ID: 700078

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Best Practices for FDA-Compliant Cybersecurity Management for Premarket Submissions of Medical Devices.

This webinar is intended to help you get familiar with the FDA-compliant management of medical device cybersecurity for regulatory purposes.This webinar is further intended to increase more...