Topic outline

  • Deviation, CAPA and Root Cause Analysis

    A course to ensure the company consistently and effectively manages deviations to ensure problems are solved and stay solved.
    Course Code COM-062
    Region 

    UK
    Delivery e-Learning
    Role Role: Other
    Competence Compliance
    Sector Sector: Pharmaceuticals

    This Course is Aimed at
    The Training Course is designed for the Responsible/Designated Persons, persons involved in Logistics and QA or any personnel involved in the distribution of pharmaceuticals.

    Overview

    The course will ensure all staff have the tools to manage all unexpected occurrences effectively.

    The learning will generate the right attitudes to support a compliance-driven approach and skill set.

    Enable interaction with a former MHRA inspector to support decision making.

    Programme Content and Key Areas

    • Deviation – problem definition, data gathering
    • Root Cause Analysis – using the appropriate method
    • Effective CAPA
    •  Achieving a state of control
    • Exercises to embed learning

    Learning Outcomes

    The learner will:

    • Appreciate the importance of applying deviation management and CAPA correctly
    • Have the ability to accurately record deviations, gather data, identify cause and effect and ensure problems ‘stay solved’
    • Be able to confidently supply all relevant information to assist with problem resolution
    • Understand the relevance of quality risk management in identifying problem areas before they occur
    • Have a greater understanding of the individual’s role in achieving a state of control within the company.

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