Title: What is CAPA and Why Is It Part of CFR 820?
Course: PW-Course-Import-Test > Section: Module 5:CAPA

Module 5

CAPA is a process discipline that can be complex depending on multiple factors.

Watch

Watch CAPA 101, an overview of a Medical Device CAPA process.

CAPA 101

Read

Read 21 CFR 820.100 (Subpart J) to see how the Corrective and Preventive Action (CAPA) fits into the regulation.

For reinforcement of CAPA objectives, revisit the Quality System Inspection Technique site for information about why the CAPA process has a critical interdependency with the Quality System Regulations. Pay particular attention to the Corrective and Preventive Actions (CAPA) Section Inspectional Objectives and the Decision Flow Chart (lower down on the page) to see how the CAPA requirements relate to CFR 820.

Read GHTF CAPA Guidance 030816.doc to gain a deeper understanding of the core objectives of a medical device CAPA process.Similar to the Design Controls Guidance that was covered in module 2, CAPA is a critical component of the regulations and consequently has an additional guidance document to help industry completely understand the process.

Read PP&C Overview CAPA 030816 to view a summary of the key high level points associated with CAPA. Pay attention to the definitions provided in this document.

Read Essential Elements of Effective CAPA Systems for an example regarding the Essential Elements of an Effective CAPA System. The regulations define the high level requirements for CAPA; however, the complete and comprehensive process may be difficult to visualize if you have never seen or been exposed to this process before.

Take this practice quiz on the next page to help reinforce the requirements of Subpart J. Then participate in the Learning Community to gain a deeper understanding of the importance of CAPA.