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FDA Quality System Regulation (QSR)

  The FDA QSR Training

FDA QSR TrainingThe FDA QSR Training module is a must for any organization that manufactures medical devices and is required to implement and comply with the Quality System Regulation. This module is designed to provide personnel with a clear understanding of the Food and Drug Administration's Quality System Regulation (QSR), 21 CFR Part 820. It is ideal for those individuals looking to fullly understand the regulation and those most likely to be responsible for implementing and maintaining the resultant quality management system.

Personnel receive an introduction to the regulation and an in-depth review of the FDA QSR requirements in simple, easy to understand language. See the preview for more details, and click on the picture to enlarge.

FDA QSR Training Preview  PDF

FDA QSR Training Preview  HTML


  FDA QSR Executive Overview

FDA QSR ExecutiveThe FDA QSR Executive Overview module is designed to provide executives who work in the medical device industry with an understanding of the FDA's Quality System Regulation (QSR), 21 CFR Part 820, and its impact on the organization.

FDA has placed increased emphasis on top management to take a more active role in ensuring their company's compliance with the Quality System Regulation.

This module helps executives understand the FDA Investigator's approach during a facility inspection by presenting FDA's Management Controls Subsystem Inspection plan and focusing on the subparts essential to Management for ensuring an effective quality management system is established and maintained.  See preview for more details, and click on the picture to enlarge.

FDA QSR Executive Overview Preview  PDF

FDA QSR Executive Overview Preview  HTML


  FDA QSR Employee Overview

FDA QSR EmployeeThis module is designed to provide personnel who work in the medical device industry with a basic understanding of the FDA's Quality System Regulation (QSR). It is best suited for orientation or company-wide QSR refresher training. Personnel are introduced to key terms and definitions and provided with a brief overview of the QSR requirements. Insight into second and third party audits is also included. See preview for more
details, and click on the picture to enlarge.

 

 

FDA QSR Employee Overview Training Module Preview  PDF

FDA QSR Employee Overview Training Module Preview   HTML


Contact QARA Compliance Connection at (813) 784-8457 or Email: info@qaracc.com for pricing and ordering information or click here to order.



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