21 CFR Part 820

21 CFR Part 820 Subpart A – General Provisions

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 first part of this program (this course) we will cover the scope of 21 CFR Part 820 and how we can establish a quality system appropriate for the medical device being manufactured.

CEU Credits: 0.1

Course Code: ELM-301

Duration: 30 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

General Provisions Subpart A

Course introduction

Learning objectives

Scope - Sec 820.1

Part 1

Part 2

Part 3

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.