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.  As a leading industry speaker, 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 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.

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)
How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

Speaker:Dr. David Lim
Time: 2nd November 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90444

Fri
02
Nov 2018

Medical Device Design: Dos and Don'ts - Special Considerations
Medical Device Design: Dos and Don'ts - Special Considerations

Speaker:Dr. David Lim
Time: 4th June 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90299

Mon
04
Jun 2018

What Medical Device Industry Should Do to Adequately Implement a Quality Risk Management System?
What Medical Device Industry Should Do to Adequately Implement a Quality Risk Management System?

Speaker:Dr. David Lim
Time: 17th May 2018 10:00 AM PDT | 01:00 PM EDT
Duration:70 Minutes
Model : GRC-90312

Thu
17
May 2018

What Pharmaceutical Industry Should do to Adequately Implement a Quality Risk Management System
What Pharmaceutical Industry Should do to Adequately Implement a Quality Risk Management System

Speaker:Dr. David Lim
Time: 21st January 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90524

Mon
21
Jan 2019

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 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: 21st December 2017 10:00 AM PDT | 01:00 PM EDT
Duration:70 Minutes
Model : GRC-90413

Thu
21
Dec 2017

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

Speaker:Dr. David Lim
Time: 15th November 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90496

Thu
15
Nov 2018

Combination Drug/Device Products CGMPs - Final Rule
Combination Drug/Device Products CGMPs - Final Rule

Speaker:Dr. David Lim
Time: 30th June 2017 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90151

Fri
30
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: 7th December 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90509

Fri
07
Dec 2018

Implementing the Best Practices for FDA Inspection Preparation and Management
Implementing the Best Practices for FDA Inspection Preparation and Management

Speaker:Dr. David Lim
Time: 28th August 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90367

Tue
28
Aug 2018

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

No recorded webinars to list here.
No cd/dvd's available.