21 CFR Part 820 Subpart H – Acceptance Activities

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 eight part of this program (this course) we will cover how each manufacturer shall establish and maintain procedures for acceptance activities including inspections, tests or other verification activities.

Curriculum for this course:
Introduction
Overview 2 mins 10 secs
ISO, ICH and the FDA 1 min 30 secs
Program organization 1 min 20 secs
Program objectives 1 min 25 secs
Definition of a medical device 1 min 50 secs
Class I, II and III 2 mins 11 secs
Intended use 1 mins 33 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
Acceptance Activities – Subpart H
Course introduction 1 min 10 secs
Learning objectives 1 min 22 secs
Acceptance activities – Sec 820.80(a) 1 min 15 secs
Incoming materials – Sec 820.80(b) 1 min 31 secs
Incoming materials – Sec 820.80(b) – An Example 58 secs
In-process materials – Sec 820.80(c) 1 min 10 secs
Final acceptance – Sec 820.80(d) 45 secs
Final acceptance – Sec 820.80(d) – Checklist 1 min 41 secs
Final acceptance – Sec 820.80(d) – Device History Record 1 min 51 secs
Establishing specifications 1 min 09 secs
Establishing specifications – continued 1 min 28 secs
Sampling plans – 100% Inspection 1 min 15 secs
Sampling plans – Acceptance quality limit (AQL) 51 secs
Sampling plans – Attribute sampling 1 min 44 secs
Where the standards came from 1 min 33 secs
The AQL levels 1 min 07 secs
Batch and lot sizes 1 min 30 secs
Other techniques 1 min 50 secs
Conclusion
Final Exam
Certification
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