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Medical Devices – Field Actions and Their Management - Recalls, Product Recovery and Safety Alerts

  March 01, 2012  
Center for Professional Innovation & Education (CfPIE), King of Prussia, PA
July 23 & 24, 2012

This course examines compliance with US 21 CFR 803, 806 and 820 regulations, and MDR and the usefulness of the Manufacturer & User Facility Device Experience database (MAUDE). The significance and meaning of the field action classification is explained together with the importance of the field action strategy and plan.  The value of knowing the European MDD/AIMD, Japanese rPAL/PMDA, Canadian and Australian requirements and reporting databases such as the MDA and ADR is explained in detail.  Additionally, what to communicate to whom allowing for time differences and national requirements, is examined.Throughout the course examples, case studies and “lessons learned” (including the significance of 3rd parties, product adulteration/misbranding) will help participants appreciate concepts being covered and provide useful insight.
Organized by: Center for Professional Innovation & Education
Invited Speakers: Contact info@cfpie.com for a list of course instructors
Deadline for Abstracts: n/a
Registration: http://www.cfpie.com/showitem.aspx?productid=091&source=hummolgen
E-mail: info@cfpie.com
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