FDA Regulations for Food, Drugs, Biologics, Medical Devices and Cosmetics

Course Description: The US Food and Drug Administration (FDA) regulates food, drugs, biologics, medical devices and cosmetics. If you are involved in FDA regulated industry, it is important to understand what regulations are applicable including relevant and applicable regulatory requirements for food, drugs, biologics, medical devices and cosmetics.
Course Objective:
This webinar is intended to help you get familiar with the US regulations governing food, drugs, biologics, medical devices including in vitro diagnostic medical devices (IVDs), and cosmetics.
This webinar will present key regulatory requirements as set out in the US regulations. To bring food and medical products to the US markets, it is imperative that firms fully understand the regulatory requirements applicable for food and medical products to obtain clearance or approval from FDA. The Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) and other statutes, if applicable, provide statutory requirements for marketing clearance, approval, registration or notification for food, drugs, biologics, medical devices including IVDs and cosmetics. In this webinar, an overview of FDA regulations applicable for food and medical products will be presented.

Course Outline:
 Statute(s) and regulations governing 510(k)s
Laws and regulations governing food, drugs, biologics, medical devices and IVDs, and cosmetics

 Good clinical practice
 Good manufacturing practice for medical devices including IVDs
 Regulatory requirements for medical devices including IVDs
Target Audience:
 Regulatory affairs
 R&D
 Quality professionals
 Complaint and risk management personnel
 Consultants

Speaker Profile : David Lim
Dr. David Lim, Regulatory Doctor, 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, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH.

Webinar Price Tags :

$ 749.00 Group Max 10 Attendees per location

$ 229.00 Single Attendee

$ 399.00 Buy Training CD-DVD

$ 269.00 Access Recorded Version online

For Further Information Or Registration ;
Phone : 866-978-0800
FAX : +1-888-883-7697

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