21 CFR Part 820

21 CFR Part 820 Subpart I – Nonconforming Products

In this course you will learn about nonconforming product and product that fails to meet a requirement, need, expectation or obligation and how each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.

CEU Credits: 0.1

Course Code: ELM-309

Duration: 60 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

Nonconforming Products – Subpart I

Course introduction

Learning objectives

Nonconforming products – Sec 820.90

Extend to other systems

Out of specification (OOS)

Management of nonconformance’s

The NCR process

Disposition decision

The material review board

The QA manager

Deviations

Deviation example

Planned deviations

Deviation systems

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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