21 CFR Part 820 Subpart E – Purchasing Controls
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 fifth part of this program (this course) we will cover all of the key aspects of purchasing controls required within a regulated medical device environment.
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 |
Purchasing Controls – Subpart E
Course introduction | 2 min 20 secs |
Learning objectives | 1 min 50 secs |
Purchasing controls – Sec 820.40 | 2 min 14 secs |
Purchasing control example | 1 min 39 secs |
Returned devices | 2 min 55 secs |
Supplier evaluation – Sec 820.50 | 2 min 14 secs |
Supplier risk assessment – Sec 820.50(a)(1) | 1 min 49 secs |
Supplier risk assessment – Sec 820.50(2) | 1 min 39 secs |
Initial evaluation tool | 1 min 30 secs |
Supplier approval and the approval supplier list -Sec 820.50(3) | 1 min 59 secs |
Key elements of a supplier agreement Part 1 | 1 min 58 secs |
Key elements of a supplier agreement Part 2 | 1 min 50 secs |
Conclusion
Final Exam
Certification
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