How to Develop an Effective Complaint Handling, and Post Market Surveillance Prog. for Drugs/Devices
11 March 2010 - 12 March 2010
Presented by: The Center for Professional Innovation & Education   -   Location: Malvern, PA USA
Contact: Michael Roberts  info@cfpie.com -  610-688-1708    http://www.cfpie.com/showitem.aspx?productid=104&source=gxp

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Upon completion of this course, attendees will have gained an understanding of how to effectively meet the requirements of post market surveillance and vigilance for medical devices and pharmaceutical products. The first day will cover the general mandates from the FDA, as well as, CE Marking, Directives 90/385/EEC and 93/42/EEC, plus Health Canada and Japan’s requirements. The second day will discuss additional regulatory topics and will review procedures to develop an effective program. General quality system topics will be covered as they relate to the post market surveillance and vigilance processes.