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Dr. David Lim
Ph.D., RAC, ASQ-CQASenior Vice President, Scientific and Regulatory Affairs |
Aquavit Pharmaceuticals, Inc., New York
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| Profile |
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 University Medical Center, US National Laboratories, Intrexon Corporation, Terumo and Center for Devices and Radiological Health (CDRH) at US Food and Drug Administration (FDA). In addition, Dr. Lim, as a licensed patent practitioner before the US Patent and Trademark Office (USPTO), had prosecuted numerous biotechnology patent applications leading to patent issuance. 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). Dr. Lim is a seasoned auditor, consultant and instructor for global regulatory, clinical and quality matters. Dr. Lim is about to pursue his final year in law school.
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| US FDA Regulations: Food, Drugs, Biologics and Medical Devices |
| Recorded Webcast |
Short
Abstract: |
United States Food and Drug Administration (“FDA”) is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe. As rules and regulations help FDA ensure that regulated products are safe and effective, it is imperative we understand the applicable regulations (Title 21 of the Code of Federal Regulations for Food and Drugs “Title 21: Food and Drugs”) and also be able to accurately interpret the said regulations to better meet the regulatory requirements necessary for FDA approval or clearance to market drugs, biologics, medical devices and food additives. In this presentation, the Title 21: Food and Drugs, the codification of the general and permanent rules and regulations (sometimes called as administrative law) for Food and Drugs, will be discussed.
The presentation will cover the following areas:
- Title 21: Food and Drugs, the codification of the general and permanent rules and regulations (sometimes called as administrative law) for Food and Drugs
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| Participants: |
CSOs, VPs, Directors, Heads, Managers working within:
- Regulatory Affairs Professionals (Associates, Specialists, Managers and Directors)
- Compliance Specialists and Officers
- Regulatory and Legal Counsel
- Quality Professionals (Associates, Specialists, Engineers, Managers and Directors).
- Research and Development (R&D) Managers and Directors
- Product and Development (P&D) Managers and Directors
- Complaint Handling and Risk Management Professionals
- Sales and Marketing Professionals
- Clinical Affairs Managers and Directors
- Site Managers, and Consultants
- Senior and Executive Management
- Anyone Interested in Learning More About US FDA Regulations
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| Recorded Webinars will be Charged a One time Fees of USD $299 |
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- The webinar focus is on strategic importance and key success factors of Good Laboratory Practice Regulations.
- Registration Fee : USD $299
- For assistance on registration, please send an email to marketing@biopractice.com or
- Please call: Ph - 1-646-216-8860
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Best Regards.
Marketing.
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