21 CFR Part 820

21 CFR Part 820 Subpart J – Corrective and Preventive Action

The Corrective and preventative actions, or CAPA, system is arguably the most important subsystem of the QMS. It is the location where issues are documented and tracked including the sources of identification, investigations, the actions taken and the verification that those actions were effective. The definitions for “Corrective Action” and “Preventative Action” are a very common source of confusion. “Corrective actions are steps that are taken to eliminate the causes of existing non-conformities in order to prevent recurrence.”

CEU Credits: 0.1

Course Code: ELM-310

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

Corrective and Preventive Action - Subpart J

Course Introduction

Learning Objectives

Corrective and Preventive Action – Sec 820.100 – Part A

Corrective and Preventive Action – Sec 820.100 – Part B

The CAPA Process

Identifying the Problem

The CAPA Team

Describing the Problem

Immediate Contaminant Plan

Root Cause Analysis

Verification

Defining & Implementing the Corrective Action

CAPA Needs to Get Documented

Acknowledging the Teams Accomplishment

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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