Global Compliance Seminar Speaker: Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com).  Dr. Lim frequently presents global regulatory and quality compliance topics at Global Compliance Seminar and 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 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.

Dr. David Lim provides regulatory consulting services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS).