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
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-302 -
Duration: 30 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
An excellent course on Subpart B, explained in such an interesting way.
A must-have online series for anyone working in the medical device sector.
Finally, an easy way to train on 21 CFR Part 820. Well done Learnaboutgmp.
The regulations delivered in an exciting way, I never thought I would be saying that!
Related courses:
21 CFR Part 820 Subpart A – General Provisions
21 CFR Part 820 Subpart B – Quality System Requirements
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart E – Purchasing Controls
21 CFR Part 820 Subpart F – Identification and Traceability
21 CFR Part 820 Subpart G – Production and Process Controls
21 CFR Part 820 Subpart H – Acceptance Activities
21 CFR Part 820 Subpart I – Nonconforming Products
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