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Introduction to 21 CFR 820 Quality System
Length of Course
1 Day
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
Level of Difficulty
Beginner (no knowledge at all of the topic).
The one day course Introduction to the FDA Quality System Regulations for Medical Devices, provides an overview of the purpose of the regulations. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).
This part establishes basic requirements applicable to manufacturers of finished medical devices.
On completion of this training, participants will be able to:
- Understand QSR Definitions, Concepts, and Guidelines
- Interpret All SubParts (A to O) of 21 CFR 820
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of a quality system