21 CFR Part 820 Subpart F – Identification and Traceability
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 sixth part of this program (this course) we will cover all of the key aspects associated with the identification and trackability of products.
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 |
Identification and Traceability – Subpart F
Course introduction | 2 min 01 secs |
Identification – Sec 820.60 | 1 min 10 secs |
Part numbers and product numbers | 2 min 13 secs |
General rules | 2 min 22 secs |
Traceability – Sec 820.65 | 1 min 10 secs |
Lot and serial numbers | 1 min 45 secs |
Typical mistakes | 1 min 55 secs |
Unique device identification (UDI) | 1 min 37 secs |
UDI requirement | 2 min 09 secs |
Conclusion
Final Exam
Certification
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