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

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 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
• Definitions
• Labeling
• Information dissemination
• Good manufacturing practice for food, drugs and biologics
• Good laboratory practice
• Good clinical practice

Target Audience:

• Regulatory affairs
• R&D
• Quality professionals
• Complaint and risk management personnel
• Consultants
• Contractors/subcontractors
• CEOs
• VPs
• Clinical affairs
• Other interested parties

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, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting.

Webinar Price Tags :

$ 229.00 Single Attendee

$ 749.00 Group – Max 10 Attendees per location

$ 269.00 Access Recorded Version online

$ 399.00 Buy Training CD-DVD

For More Details or Enrollment Or Registration :

Contact : complianzworld

Phone : +1-866-978-0800

Fax : +1-888-883-7697

E-mail ID : webinarhelp@complianzworld.com

Webinar Website :  http://complianzworld.com/Webinars.aspx?TopicId=491&Sub=FDA-Regulations-for-Food,-Drugs,-Biologics,-Medical-Devices-and-Cosmetics