GDP, GCLP, GLP, GMP
Face-to-face and blended
learning for corporate clients
gcp trainee

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 of

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)

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