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advanced level21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)
3-4hrs
diplomaTeaching & Academics
Medical device manufacturers willing to produce or place their products in the US market must comply with a regulatory standard called 21 CFR Part 820. If you are a regulatory professional working in this niche, enrolling in this course will give you a solid understanding of this standard. With this course, you will clearly learn about each subpart of the standard. It will also prepare you for the FDA inspection and related procedures.
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21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)
Acquire a straightforward interpretation of the 21 CFR Part 820 standard for QSR in the US medical device industry.
Medical device manufacturers willing to produce or place their products in the US market must comply with a regulatory standard called 21 CFR Part 820. If you are a regulatory professional working in this niche, enrolling in this course will give you a solid understanding of this standard. With this course, you will clearly learn about each subpart of the standard. It will also prepare you for the FDA inspection and related procedures.
Course description
Course module
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Module 15 Lessons
The Basics of 21 CFR Part 820
This module introduces you to 21 CFR Part 820. It will teach you the importance of having a QMS in the medical device manufacturing industry and explain all fifteen subparts of 21 CFR Part 820 concisely.
1.Learning Outcomes
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2.Introduction to 21 CFR Part 820
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3.21 CFR Part 820 - Subparts B to G
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4.21 CFR Part 820 - Subparts H to O
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5.Lesson Summary
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Module 25 Lessons
21 CFR Part 820, ISO 13485, and FDA Inspections
Module 31 Lessons
Course assessment
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