21 CFR Part 820

21 CFR Part 820 Subpart G – Production and Process Controls

In this course you will learn about how each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

CEU Credits: 0.1

Course Code: ELM-307

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

Production and Process Controls – Subpart G

Course introduction

Learning objectives

Specification, alert limits and action limits – Sec 820.70(a)

Product and process control – Sec 820.70(b)

Document and product design changes

Personnel controls – Sec 820.70(d)

Environmental and contamination control – Sec 820.70(c)(e)

Buildings and facilities – Sec 820.70(f)

Equipment controls – Sec 820.70(g)

Custom & off the shelf equipment

Equipment validation process - FAT

Equipment validation process - SAT

Maintenance schedule

Calibration program

Logbooks

Maintenance action plan

Maintenance schedule cards

Manufacturing material / Line clearance – Sec 820.70(h)

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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