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  • Training

Introduction to the Quality System Regulation

This course provides knowledge on Good Manufacturing Practices (GMPs) which are in place to help protect medical devices and medical device users as specified in the Quality System Regulation (QSR).

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Description

Good Manufacturing Practices (GMPs) help protect medical devices and medical device users. This course describes the GMPs for medical devices as specified in the Quality System Regulation (QSR). Topics in this course include quality system, design control, software validation and responsibility. After completing this course, learners will be able to identify the components of a quality system, design controls and software validation.

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Duration

30 minutes

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Library

Medical Device GMP, FDA Inspections and Enforcement

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Functional area

Medical Device and GMP, Quality System Regulations and Inspections, GMP Basics

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