Device Master Record & Device History Record - A Regulatory
Автор: GlobalCompliance Panel
Загружено: 2016-06-06
Просмотров: 1934
Understanding of the what these two important parts of a GMP compliant quality management system are, and how they are established, implemented and controlled.
Two key elements of the Quality System Regulation requirements for the FDA cGMP are the Device Master Record and the Device History Record. These requirements are outlined in paragraphs 820.181 and 820.184 respectively. This Video will outline the requirements for each of these two elements in significant detail to allow a device manufacturer to understand the requirements of these very important QSR elements for the medical device industry.
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