21 CFR Part 820 Subpart B – Quality System Requirements

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 second part of this program (this course) we will cover management requirements, quality audits and personnel.

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
Quality System Requirements – Subpart B
Course introduction 2 mins 10 secs
Learning objectives 1 min 58 secs
Management responsibility – Sec 820.20(a) Part 1 2 mins 15 secs
Management responsibility – Sec 820.20(a) Part 2 1 min 28 secs
Organizational structure – Sec 820.20(b) 1 min 18 secs
Separation between quality and production – Sec 820.20(b)(1) 2 mins 07 secs
Organizational chart – Sec 820.20(b)(2) 1 min 57 secs
Management representative – Sec 820.20(b)(3) 2 mins 33 secs
Management review – Sec 820.20(b)(c) 1 min 45 secs
Quality planning – Sec 820.20(d) 2 mins 18 secs
Quality audits – – Sec 820.22 2 mins 11 secs
Internal quality audits 1 min 39 secs
Supplier audits 2 mins 22 secs
Qualification requirements 1 min 51 secs
Audit teams 1 min 37 secs
First, second and third party audits 2 mins 31 secs
Audit plan 1 min 30 secs
Audit terminology 2 mins 19 secs
Audit example 1 min 39 secs
Audit example (Cont'd) 1 min 42 secs
Personnel – Sec 820.25 2 mins 41 secs
Training – Sec 820.25(b) 1 min 50 secs
Documented 2 mins 57 secs
Personnel notified of defects – Sec 820.25(b)(1)(2) 1 min 39 secs
Process change 2 mins 09 secs
Personnel Vs employee file 2 mins 36 secs
Conclusion
Final Exam
Certification
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