Understanding FDA’s Medical Device Quality System Regulation

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.

For companies interested in learning about ISO 13485:2016 see our related course – Understanding an ISO 13485 Quality Management System – or for a comprehensive understanding of US and international regulations see our course Quality Systems for Medical Devices: FDA’s QSR and ISO 13485:2016.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.


There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

In-Person Agenda▸

Objectives

At the end of this workshop, participants will be able to:

Understand the purpose, benefits, and objectives of FDA’s Medical Device Quality System Regulation (QSR).
Analyze the meaning of the elements of the QSR.
Compare the relationship between standards and guidance documents in support of FDA compliance initiatives.
Understand international harmonization efforts and their effects.
Learn how to read FDA warning letters and recognize situations that warrant warning for QSR deficiencies.
Map the requirements of the QSR versus your system and establish audit evidence to support FDA compliance.
Know when ISO 13485 compliance is required.

Topics

The Quality System Regulation (QSR) – an integral aspect of the management system
QSR background
QSR subpart reviews
Recent FDA inspectional observations

Who Should Attend

Designed for 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.

In-Person Days: 2
CEUs: 1.5