21 CFR Part 820

21 CFR Part 820 Subpart H – Acceptance Activities

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.

CEU Credits: 0.1

Course Code: ELM-308

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

ISO, ICH and the FDA

Program organization

Program objectives

Definition of a medical device

Class I, II and III

Intended use

History of 21 CFR Part 820

21 CFR 820 Timeline

1906 - The Jungle

1937 - Massengil Company

1957 - Thalidomide

1971 - Dalcon Corporation

1990 - FDA device recall report

A regulatory evolution

Acceptance Activities - Subpart H

Course introduction

Learning objectives

Acceptance activities – Sec 820.80(a)

Incoming materials – Sec 820.80(b)

Incoming materials – Sec 820.80(b) – An Example

In-process materials – Sec 820.80(c)

Final acceptance – Sec 820.80(d)

Final acceptance – Sec 820.80(d) - Checklist

Final acceptance – Sec 820.80(d) – Device History Record

Establishing specifications

Establishing specifications – continued

Sampling plans – 100% Inspection

Sampling plans – Acceptance quality limit (AQL)

Sampling plans – Attribute sampling

Where the standards came from

The AQL levels

Batch and lot sizes

Other techniques

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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