Understanding of FDA 21 CFR Part 820-Quality System Regulation
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This two day training course will give you a good understanding of the FDA 21 CFR 820, Quality System Regulation (QSR).
The medical device industry is highly regulated due to the product risk to health, and one of the requirements is to establish and maintain a quality management system. Although the rest of the world complies with ISO 13485 standard, the United States requires compliance to the 21 CFR 820, Quality System Regulation (QSR).
The QSR, specifying current Good Manufacturing Practices for medical devices, was established in 1997 based on earlier structure of ISO 9001 and ISO 13485, as well as the EN 46001 standards. Although ISO 9001 and ISO 13485 were restructured recently (2015 and 2016), the QSR structure remains unchanged, thus fairly different from the requirements. Besides the structure, there are terms and specific requirements of the QSR which are not in the ISO standards.
Understanding the QSR is essential to ensure compliance to the United States regulatory requirements and to prepare for an eventual visit from the FDA.