FDA QSR Executive Overview

A One-Day Primer


The FDA Quality System Regulation includes the requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of all finished medical devices intended for human use. The QSR is designed to provide manufacturer’s of finished medical devices with a framework of basic requirements to use in establishing a quality management system appropriate to the devices designed and manufactured and the manufacturing processes employed. The principles embodied by the regulation have been accepted worldwide as a means of ensuring that acceptable products are produced.

This Course is for you if:

  • You manufacture or would like to manufacture medical devices for sale in the U.S. and you need to understand the quality system regulations affecting these devices.
  • You are responsible for managing, implementing, and/or adhering to a quality management system compliant with the FDA Quality System Regulation.
  • You would like to understand the quality system regulation requirements and their significant impact on your organization.


$400 per person (5 person min)
$350 each additional over 5

Course Outline


What is CGMP or FDA QSR?

  • History
  • Scope

Internal Company Benefits

Key Terms and Definitions

QSIT Approach/Technique

QSIT Program Results

Four Major Themes

  • Management
  • Design Controls
  • Production & Process Controls
  • Corrective & Preventive Action

Company-Wide Activities

Specific Requirements

Interrelation Between Sections

Establish & Maintain Procedures

Where Appropriate

Executive Management’s Role

1998 FDA Statistics


QA/RA Compliance Connection, Inc. * P.O. Box 448 * Odessa, Florida 33556 * (813) 784-8457