Live Webinar
on
Title 21, Code of Federal Regulations for Food and Drugs
Date & Time: Thursday, March 29, 2012
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: David Lim
Location: Online
Price : $245.00
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Instructor Profile:
Overview:
David Lim Chairman and CEO, Regulatory Doctor
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.
Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. ...more
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 webinar, 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.
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Title 21: Food and Drugs ¡ Who makes it? ¡ How it is organized? ¡ How often it is revised? Food Drugs Biologics
Medical Devices Cosmetics Good Laboratory Practice (GLP) Investigational New Drug Application (IND) Investigational Device Exemption (IDE) Recent enforcement actions for food, drugs, biologics and medical devices, etc.
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