Face-to-face and blended
learning for corporate clients
CAPA (Corrective And Preventative Action) for GCP Compliance
Duration: 1 day
Key Objectives:
Understand CAPA Methodology and Documentation for GCP compliance
Discover how you can Address Inspection Findings using CAPA and Process Improvement
Who should take this course?
The course has been specifically designed for Pharma, Biotechnology, and Academic Research organisations and particularly if you are involved in GCP process improvement, corrective and preventative action, and managing inspections and documenting how to deal with these.
Course Syllabus:
1. Introduction and Objectives
2. CAPA Methodology and Documentation
• Identification – clearly define the problem
• Evaluation – appraise the magnitude and impact e.g. scenarios, test out assumptions
(Using the Uncertainty – Importance grid to help identify potential risks etc)
• Investigation
• Analysis – perform a thorough assessment – review data, prioritise, develop options for
solutions
• Action Plan – create a list of required tasks
• Implementation – execute the action plan, e.g. stakeholder analysis, the transition curve
• Follow Up – verify and assess the effectiveness of the CAPA
• Finding(s)
3. Diagnosing CAPAs
• Using problem diagnosis (for example, root cause analysis) for understanding why
processes are cumbersome and to help facilitate resolving audit and inspection findings
4. Developing Options for solving CAPA
• Evaluation of the attractiveness/likely difficulty of changes (“AID” analysis)
• Continuous improvement – as an invaluable approach for improving the implementation
or GCP CAPA
5. Planning and Implementation for CAPA
• Project managing process for CAPA
• Managing the change and people issues
• Managing the stakeholders involved (stakeholder analysis)
