Design Control for Medical Device Professionals
Course - Berlin, Germany
This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.
Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.
Upon completion of this course, attendees will have an understanding of the framework for Design Control and recommendations to effectively meet the requirements of Design Control. Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.
Through the use of interactive instruction, this course will cover the general context for design control, quality systems, standards, and recommended design control procedures. Special attention is given to implementation aspects of key parts of design control. Manufacturing transfer and general quality system topics will be covered as they relate to the design process. Several exercises will be completed by attendees to reinforce key concepts. Participants will receive extensive course notes that are designed to be used as reference material once the course is completed
(Courtesy of http://www.cfpie.com/)
Mon, Sep 10, 2012 - Tue, Sep 11, 2012
The Berlin Hilton
Mohrenstrasse 30, Berlin, Germany
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