QS Regulation 1: Overview and General Provisions

<p>This course introduces the Quality System (QS) Regulation (21 CFR Part 820) — a framework of basic requirements for manufacturers of finished medical devices. The course covers the history of the regulation, as well as its requirements, scope, and key terms. The course also discusses the manufacturer’s responsibility for a quality system under this regulation. Topics in this course include: Origin, QS Regulation, Terms, Scope, and Responsibility. After completing this course, learners will be able to recognize the origin and scope of the QS Regulation. You will also be able to identify the purpose of the Preamble and general requirements of a quality system. Finally, you will be able to recognize key definitions.</p>

After this course learners will be able to recognize the origin and scope of the qs regulation. identify the purpose of the preamble and general requirements of a quality system. recognize key definitions.