Title: Module 5 Overview: CAPA
Course: PW-Course-Import-Test > Section: Module 5:CAPA

Module 5

In this module we will explore 21 CFR 820.100 Corrective and Preventive Action (CAPA). The CAPA process is essentially the “engine” that drives a compliant Medical Device Quality system. The ability to internally “self” detect and correct quality, performance and compliance issues is paramount with respect to producing safe and effective medical devices.

Read

Corrective and preventive action, Wikipedia’s definition of CAPA.

Watch

Watch the short CAPA video

Watch this video, which presents an example of an electronic CAPA management system.

CAPA Management Overview

Many of the larger medical device firms use a software tool like this one to manage their CAPA process.

Competency

After completing this module, you will be able to explain the purpose of a CAPA system and how it used in a regulated medical device environment.

Learning Objectives

- Identify/describe why a compliant CAPA process is needed.
- Compare and contrast the three (3) key CAPA objectives (e.g. Corrections, Corrective Actions, Preventive Actions) and the differences between them.
- Sequence a high level process flow chart for a medical device CAPA process
- Illustrate the difference between CAPA implementation and CAPA effectiveness

Click Next to move sequentially through this module.