Medical device coursework is developed and administered to satisfy specific disciplines and enhancing cross-discipline exposure. Medical device training program attendees benefit from lively discussions with peers in an open, interactive setting. The discussion of real-world experiences amongst the instructor and participants allows for expanded viewpoints that can benefit employees daily.

This course provides a focused introduction to the background and requirements of FDA’s Quality System Regulation (QSR). This course covers the QSR subpart by subpart to identify the requirements.

The British Academy for Training and Development offers this course to the following categories:

• Those who need to understand and apply the requirements of the QSR, including R&D managers; engineering managers; management representatives.
• Product, project, and program managers; RA/QA managers/engineers.
• Internal auditors; and other cross-functional team members.

After completing the program, participants will be able to master the following topics:

• Analyze the meaning of the elements of the QSR.
• Understand the purpose, benefits, and objectives of FDA’s Medical Device Quality System Regulation (QSR).
• Compare the relationship between standards and guidance documents in support of FDA compliance initiatives.
• Learn how to read FDA warning letters.
• Recognize situations that warrant warning for QSR deficiencies.
• Map the requirements of the QSR
• Establish audit evidence to support FDA compliance.

• Introduction to Medical Device Regulation (MDR).
• The Quality System Regulation (QSR) – an integral aspect of the management system.
• QSR background.
• QSR subpart reviews.
• Recent FDA inspectional observations.