21 CFR Part 820

21 CFR Part 820 Subpart B – Quality System Requirements

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 second part of this program (this course) we will cover management requirements, quality audits and personnel.

CEU Credits: 0.1

Course Code: ELM-302

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

Quality System Requirements - Subpart B

Course introduction

Learning objectives

Management responsibility - Sec 820.20(a) Part 1

Management responsibility - Sec 820.20(a) Part 2

Organizational structure - Sec 820.20(b)

Separation between quality and production - Sec 820.20(b)(1)

Organizational chart - Sec 820.20(b)(2)

Management representative - Sec 820.20(b)(3)

Management review - Sec 820.20(b)(c)

Quality planning - Sec 820.20(d)

Quality audits - - Sec 820.22

Internal quality audits

Supplier audits

Qualification requirements

Audit teams

First, second and third party audits

Audit plan

Audit terminology

Audit example

Audit example (Cont'd)

Personnel - Sec 820.25

Training - Sec 820.25(b)

Documented

Personnel notified of defects - Sec 820.25(b)(1)(2)

Process change

Personnel Vs employee file

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.