21 CFR Part 820

21 CFR Part 820 Subpart F – Identification and Traceability

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 sixth part of this program (this course) we will cover all of the key aspects associated with the identification and trackability of products.

CEU Credits: 0.1

Course Code: ELM-306

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

Identification and Traceability – Subpart F

Course introduction

Identification – Sec 820.60

Part numbers and product numbers

General rules

Traceability – Sec 820.65

Lot and serial numbers

Typical mistakes

Unique device identification (UDI)

UDI requirement

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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