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
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-308 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes
Reviews:
This course really helped me understand the importance of acceptance activities and the governing regulations.
Another great addition to the 21 CFR Part 820 learning path. This resource is critical to us as a medical device manufacturer.
Easy to understand and presented in an engaging manner. This is exactly how I like to learn.
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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