21 CFR Part 820

21 CFR Part 820 Subpart D – Document Controls

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 fourth part of this program (this course) we will cover document controls and their overall lifecycle.

CEU Credits: 0.1

Course Code: ELM-304

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: 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

Document Controls - Subpart D

Course introduction

Learning objectives

Document controls - Sec 820.40

Document hierarchy

Document approval - Sec 820.40 (a)

Document revision

Document revision control - Part 1

Document revision control - Part 2

Release Date and Effective Date

Document change control - Sec 820.40 (b)

Change control approves

Change control notifications

Document retirement

Living documents

Good document writing

Clear and concise

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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