Process Validation for Medical Devices
Course - King of Prussia, PA, United States
This three-day course is targeted toward professionals involved in meeting both the international and FDA's Quality System Validation requirements including those in: regulatory affairs, quality assurance, process development or manufacturing. To maximize peer learning opportunity, this course is recommended for those who may have a basic understanding of the Quality System Regulation (QSR) and/or ISO 13485, including direct work experience.
This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The course is also intended for medical device professionals who are responsible for performing process validation studies and ensuring compliance with regulatory requirements for validation documentation.
(Courtesy of http://www.cfpie.com/)
Wed, Sep 12, 2012 - Fri, Sep 14, 2012
Doubletree Hotel by Hilton, Philadelphia/Valley Forge
301 West Dekalb Pike, King of Prussia, PA 19406, United States
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