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FDA QSR (21 CFR 820)


The FDA QSR Executive Overview module is ideal for training executives who work in the medical device industry and who are mandated to implement a quality management system that complies with the Quality System Regulation 21 CFR Part 820. Every organization's management team needs to understand the requirements that pertain to their area of responsibility and authority. Executives need to also under- stand the QSR's impact on the organization.

The FDA QSR Executive Overview module is designed to provide executives with a basic knowledge and understanding of the Food and Drug Administration's Quality System Regulation (QSR). FDA has placed increased emphasis on top manage- ment to take a more active role in ensuring their company's compliance with the Quality System Regulation. The module includes an introduction to Current Good Manufacturing Practice (CGMP) history and discusses some key terms cited in the regulation. Organizational benefits associated with implementation and compliance with the regulation are also highlighted.

This module helps executives understand the FDA Inspector's approach during a facility inspection/audit by presenting the QSR's four major themes as depicted by the FDA's Quality System Inspection Technique (QSIT). Results from some actual facility inspections using this technique are illustrated to show common problem areas.

The module includes a detailed review of the four major themes of the Quality System Inspection Technique and provides an overview of the remaining sections broken down by company-wide activities and specific department related activities in simple, easy to understand language. The FDA QSR Executive Overview module identifies where procedures are required and where documentation is appropriate.

Four Key Themes

Management Responsibilities

Design Controls

Production and Process Control (PAPC)

Corrective and Preventive Action (CAPA)

Course Outline

- QSR History/Introduction
- Internal Company Benefits
- Key Terms & Definitions
- QSIT Approach/4 Themes
- Company-Wide Requirements
- Specific Requirements
- Interrelation btw Sections
- Establish & Maintain Procedures
- Where Appropriate
- Your Role
- Concluding Remarks

CGMP History

  • Manufacturer's establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.
  • The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as CGMP's
  • CGMP = Current Good Manufacturing Practice
  • CGMP's were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(f)) as a result of the Medical Device Amendment of 1976.

Management Responsibility
Outline Documentation Structure

FDA QSIT Breakdown
By QSIT Theme

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