21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)

Name: 21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)
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Acquire a straightforward interpretation of the 21 CFR Part 820 standard for QSR in the US medical device industry.

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Learning Outcomes

In this free course, you will learn how to:

Indicate the scenarios where finished devices should not be released into the market
Explain all the fifteen subparts of 21 CFR Part 820 in a simplified manner
Recognize the importance of internal audits in showing compliance with 21 CFR Part 820
Identify the different types of FDA inspections
Outline the ways to take Corrective and Preventive Actions (CAPA) in the light of 21 CFR Part 820
Describe the process to show compliance with the requirements of 21 CFR Part 820
State the major ways a medical device manufacturer can prepare themselves beforehand for an FDA inspection
Identify the subparts of 21 CFR Part 820 and their main requirements
List the significant benefits of medical device manufacturers after showing compliance with a QMS

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