CAPA within the Pharmaceutical Quality System

Industrial Management Consulting
Industrial Management Consulting

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What is CAPA per ICH Q10?
(Corrective and Preventive Actions)
A structured approach to the investigation process should be used with the objective of determining the root cause.

The level of effort, formality, and documentation of the investigation should be commensurate with the
level of risk, in line with ICH Q9.

Agenda
 What is CAPA?
 Other Industries
 Case Study:
How CAPA developed in Biotech
 The Desired State
 Enablers for an Effective CAPA System
 Lessons Learned
 Summary

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Continue at: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/ucm334579.pdf

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