Dr. David Lim

Speaker Profile :

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) 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.


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Best Practices for FDA Inspection Preparation and Management
This webinar is intended to help you get familiar with the best practices for FDA inspection preparation and management integrated with emotional intelligence (..

Live Session By Dr. David Lim On Friday 27th of September 2019 10:00 AM PDT | 01:00 PM EDT
$195.00
Fundamentals of Regulatory Affairs in Human Drugs
Why you should attend:      To understand and become familiar with the Fundamentals of Regulatory Affairs in Drugs   Topic De..

Live Session By Dr. David Lim On Friday 13th of September 2019 10:00 AM PDT | 01:00 PM EDT
$195.00
FDA 510(k): Preparation, Submission, and Clearance Medical Devices
This webinar is intended to discuss regulatory requirements for FDA 510(k)s: in particular, 510K) preparation, submission and a successful clearance under the c..

Live Session By Dr. David Lim On Wednesday 21st of August 2019 11:00 AM PDT | 02:00 PM EDT
$195.00
Use of Excel Spreadsheets in FDA-Regulated Environments under 21 CFR Part 11
Why you should attend: This seminar will provide great opportunities to improve our awareness and better implement part 11 and computer system validation re..

Live Session By Dr. David Lim On Wednesday 21st of August 2019 10:00 AM PDT | 01:00 PM EDT
$195.00