Center for Professional Innovation & Education (CfPIE), King of Prussia, PA
Jan. 23 – 25, 2012
This three-day course is targeted toward individuals directly involved in meeting the international and FDA's Quality System Validation requirements including those in regulatory affairs, quality assurance, process development or manufacturing. Participants will learn how to comply with FDA and international regulations for medical device validation protocols and determine the format and function of such protocols. Attendees will also learn how to maintain adequate validation documentation systems and perform equipment qualifications, process and software validations, and evaluate the need for re-validations.
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