Corrective and Preventative Action (CAPA) – Mistakes occur, we all understand that, but not reacting to them is as far as our customers are concerned, unforgiveable. Reacting not just to the immediate problem and its consequences, but also addressing longer term corrective and preventive actions – ensuring the problem never happens again.
CAPA (Corrective and Preventive Action) is about addressing issues, problems, incidents or accidents in a structured, methodical manner using widely accepted approaches and techniques which provide evidence and confidence to the customer that the organisation concerned as acted with due diligence, which includes documented evidence, supporting the conclusions and consequential actions taken.
Global regulatory agencies in the healthcare industries such as FDA, EU regulators and MHRA and the financial FSA or FCA (Financial Conduct Authority) are all targeting Corrective and Preventive Action (CAPA) systems during their routine inspections, to determine an organisation’s ability to supply products and services that are consistently fit for purpose. Common issues raised by these regulatory agencies include:
To enable delegates to:
Reason for CAPA:
The CAPA course is broken down into the natural CAPA four-phase processes:
Together with presenting practice examples of CAPA techniques and case studies
1. Pre-course visit to develop and adapt the course and associated material to suit the client’s needs.
2. Pre and post course delegate assignment with QM&T support. The delegate’s assignment / project would be fully assisted and supported online and assessed by one of our qualified and experienced staff. This work based assignment approach has regularly provided significant financial savings, reinforce lessons learnt and provided a practical demonstration of delegate competence. This (on successful assignment completion) provides the delegates with a QM&T Practitioner certificate. This approach is often useful where delegates may not (due to other pressures) be able to immediately apply the newly acquired knowledge.
3. Delegate assignment presentation provides the delegate with the opportunity to demonstrate their achievements to a selected group such as; CEO and Directors, key Managers and Supervisors, etc. This gives the delegate the opportunity to credit and recognise their performance and motive others to emulate.
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