Overview:

ITS’ Understanding Corrective and Preventive Action Systems (CAPA) Training Course provides an understanding of how to run effective Corrective and Preventive Action (CAPA) systems that will benefit your business and satisfy the regulators.

The CAPA training course covers areas that can cause confusion including terms, definitions, deviations, non-conformances and use of corrections, corrective and preventive actions.

Course activities include applying the CAPA system and root cause analysis to a potential real case scenario.

Content:

• Investigate what a CAPA system is

  • Terms, acronyms and their application

  • What is CAPA and why is there so much emphasis on the use of CAPA in the regulated industry?

  • How utilising the Global Harmonization Task Force’s structured approach to CAPA can help cure problems

  • How the overall approach of CAPA is meant to work, including the links to change control

• Consider regular misconceptions of CAPA systems, and misinterpretation of terms

  • If a corrective action is instigated then there must be preventive action implemented … or not?

  • The use of the terms corrections, corrective actions and preventive actions

• Reflect on regulatory expectations

  • Regulatory requirements

  • Review common system and human failings that have a negative effect on CAPA and the business

  • Common FDA and EU regulator inspection findings including FDA warning letters

• Investigate use of root cause analysis to determine needs for a correction, corrective action and what may be a preventive action

  • Review of different methods such as Cause and Effect, Flow and Process Charts, Mind Mapping

  • Utilise risk management techniques

  • Documenting CAPA activities

• Investigate the subject of Human Error

  • Review human characteristics and factors that could play a role in human error

  • Identify different types of human failure

  • Review ways of addressing human failure

• Apply and review CAPA case studies to enhance course learning

  • Identify potential deviations and what needs to be done

  • Use different potential real activities to apply CAPA

• Review learning and summarise effective CAPA systems

  • Personal reflection and group summary of how to define effective CAPA systems