ComplianceOnline

Expert Profile


David Lim
Senior Vice President, Aquavit Pharmaceuticals

Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia in 1993. Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo and Center for Devices and Radiological Health (CDRH) at US Food and Drug Administration (FDA). Currently, Dr. Lim is Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc., in New York. Prior to Aquavit Pharmaceuticals, Dr. Lim served as Director of Regulatory Affairs at EraGen Biosciences, Inc., A Luminex Company in Madison, WI. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ).

Trainings by Expert

3-hr Virtual Seminar: Medical Device Regulations and Law in the US, EU and Canada
Category: Medical Devices , Regulations & Guidances , Life Sciences , Documentation and Data Management

3-hr Virtual Seminar- Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada
Category: Medical Devices , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
Category: Clinical Research , Clinical Trial Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs , Roles and Responsibilities

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals
Category: Medical Devices , All FDA Regulated Industry , Marketing and Promotion , Crisis Management , Documentation and Policy Management , Lifescience process & Procedures , Best Practices & GXPs , Life Sciences , Documentation and Data Management

cGMPs for Medical Devices, Including In Vitro Diagnostic Devices
Category: Medical Devices , All FDA Regulated Industry , IVD , Supply Chain and Manufacturing , Best Practices & GXPs , Life Sciences

Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea
Category: Medical Devices , Clinical Research , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Outsourcing , Clinical Trial Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Global Medical Device Laws and Regulations: US, EU, and Canada
Category: Medical Devices , Clinical Research , Marketing and Promotion , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Outsourcing , Clinical Trial Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

US FDA 510(k): Best Practices for 510(k) Preparation and Submission
Category: Medical Devices , Clinical Research , Marketing and Promotion , QMS, ISO 13485, CAPA , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Audit and Inspection , Documentation and IT , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Laboratory , Quality & Safety , Food & Dietary Supplements , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , Quality Audit , Food Safety Audit , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Fraud in Clinical Research
Category: Clinical Research , Ethics, Fraud and Misconduct , Clinical Trial Regulations , Compliance & Ethics , Regulations & Guidances , Life Sciences , Regulatory Affairs