Understanding FDA’s Medical Device Quality System Regulation

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.

Related Courses

• Understanding an ISO 13485 Quality Management System 
• Quality Systems for Medical Devices: FDA’s QSR and ISO 13485:2016.