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2012 - Title 21, Code of Federal Regulations for Food and Drugs - Webinar By GlobalCompliancePanel

Date2012-03-29

Deadline2012-03-29

Venueonline tra, USA - United States USA - United States

Keywordsonline training,Title 21, Code of Federal Regulations,Good Laboratory Practice ,GLP,Investigational New Drug Application ,IND,Investigational Device Exemption,IDE

Websitehttp://www.globalcompliancepanel.com

Topics/Call fo Papers

Overview: 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 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.
Why should you attend: If you don't know the answers to the following questions, you should attend this webinar.
Who makes federal regulations?
Who makes FDA regulations?
How the federal regulations are organized?
Which provisions of FDA regulations are applicable for regulating the following?
Food
Drugs
Biologics
Medical devices
Cosmetics
Combination products
What regulatory requirements exist for the following?
Good Laboratory Practice (GLP)
Investigational New Drug Application (IND)
Investigational Device Exemption (IDE)
Areas Covered in the Session:
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.
Who Will Benefit:
Regulatory Affairs Associates, Specialists, Managers, Directors and VPs
Quality Associates, Specialists, Engineers, Managers, Directors and VPs
Compliance Specialists and Officers
Research and Development (R&D) Managers, Directors and VPs
Product and Development (P&D) Managers, Directors and VPs
Complaint Handling and Risk Management Managers and Directors
Sales and Marketing Managers and Directors
Clinical Affairs Managers and Directors
Site Managers, Directors, and Consultants
Senior and Executive Management
Legal Counsel
Anyone Interested in Learning About US FDA Regulations
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884

Last modified: 2012-02-24 18:14:23