21 CFR Part 820 Subpart A – General Provisions

Description:

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Administration (FDA) guidance documents, as well as other standards in order to provide clarification on how 21 CFR 820 is interpreted and enforced. In the first part of this program (this course) we will cover the scope of 21 CFR Part 820 and how we can establish a quality system appropriate for the medical device being manufactured.

Curriculum for this course:
Introduction
Overview 2 mins 10 secs
ISO, ICH and the FDA 2 min 30 secs
Program organization 1 min 25 secs
Program objectives 1 min 50 secs
Definition of a medical device 2 mins 11 secs
Class I, II and III 2 mins 33 secs
Intended use 2 mins 10 secs
History of 21 CFR Part 820
21 CFR 820 Timeline 1 min 50 secs
1906 – The Jungle 1 min 45 secs
1937 – Massengil Company 2 min 10 secs
1957 – Thalidomide 1 min 58 secs
1971 – Dalcon Corporation 2 mins 33 secs
1990 – FDA device recall report 2 min 10 secs
A regulatory evolution 1 min 30 secs
General Provisions Subpart A
Course introduction 1 min 20 secs
Learning objectives 1 min 55 secs
Scope – Sec 820.1 1 min 02 secs
Part 1 1 min 25 secs
Part 2 1 min 45 secs
Part 3 1 min 38 secs
Conclusion
Final Exam
Certification
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