Speaker Profile


Dr. David Lim

MDA

President and Principal of Regulatory Doctor

Dr. David Lim, Ph.D., RAC, ASQ-CQA.Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). Dr. Lim frequently presents global regulatory and quality compliance topics 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 eight 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 pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Best Practices for Preparing for a Technical File for CE Mark
Best Practices for Preparing for a Technical File for CE Mark

Speaker:Dr. David Lim
Time: 26th August 2016 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90037

Fri
26
Aug 2016

FDA Inspection Policy and Best GMP Practices
FDA Inspection Policy and Best GMP Practices

Speaker:Dr. David Lim
Time: 18th November 2016 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90060

Fri
18
Nov 2016

FDA Regulations Governing GCP, GLP and GMP
FDA Regulations Governing GCP, GLP and GMP

Speaker:Dr. David Lim
Time: 5th December 2016 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90069

Mon
05
Dec 2016

Understanding the US FDA Drug Review and Approval Process
Understanding the US FDA Drug Review and Approval Process

Speaker:Dr. David Lim
Time: 11th April 2017 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90110

Tue
11
Apr 2017

Implementing a Unique Device Identification (UDI) System
Implementing a Unique Device Identification (UDI) System

Speaker:Dr. David Lim
Time: 22nd June 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90130

Thu
22
Jun 2017

510(K) Submission - A Comprehensive and an Updated Overview
510(K) Submission - A Comprehensive and an Updated Overview

Speaker:Dr. David Lim
Time: 16th November 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90188

Thu
16
Nov 2017

FDA Inspection Policy and Best GMP Practices
FDA Inspection Policy and Best GMP Practices

Speaker:Dr. David Lim
Time: 9th August 2017 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90173

Wed
09
Aug 2017

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No cd/dvd's available.