Course Description

Overview of US FDA Quality System Regulation

Course Description:

This course presents a highly informative overview of the US FDA’s Quality System Regulation (QSR). It explains what a QSR is and how it works, including management and design controls, production and process controls, and post-production requirements.

According to the US FDA’s QSR for medical devices, all manufacturers are required to establish quality systems to ensure that their products consistently meet the standard requirements and specifications. This course examines the key QSR requirements and what a quality system must include to be compliant with the QSR.

Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Identify and comprehend the basis of the US FDA QSR and its provisions
  • Distinguish the key differences between the US FDA QSR and ISO 13485
  • Acquire insight on which key areas of the QSR the FDA emphasizes the most
  • Discern how the FDA interprets important QSR provisions

Who Should Enroll:

Medical device professionals who are responsible or involved in compliance with the US FDA QSR are encouraged to take this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.

Subject Matter Expert:
Maria E. Donawa

75 min

Related resources:

Case studies:

Basic Account: € 330.00
Premium Account: € 248.00

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