Topic outline

  • Quality Risk Management in Distribution

    A one-day course presented by former MHRA inspectors to enable the correct use of Quality Risk Management in pharmaceutical distribution. The course follows ICHQ9 as recommended by EU GDP and MHRA to achieve a state of control. The approach is primarily proactive to ensure compliance but can be applied reactively.


    Course Code COM-063
    Region 

    UK

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

    This Course is Aimed at

    The Responsible/Designated Persons, persons involved in Logistics and QA or any personnel involved in the distribution of pharmaceuticals. 

    Overview

    The course will provide instructions and practical examples to ensure all staff have can competently use Risk Management tools to achieve a continued state of compliance.

     Learners will develop the right attitudes to support a compliance-driven approach and skill set.

     The day will enable interaction with a former MHRA inspector to support decision making.

    Programme Content and Key Areas

    Key topics:

    • Risk Identification
    • Risk Analysis
    • Risk Evaluation
    • Risk Reduction
    • Risk Acceptance
    • Risk Review
    • Achieving a state of control
    • Exercises to embed learning

    Learning Outcomes

    The learner will:

    • Be able to apply the principles of quality risk management to identify problem areas before they occur
    • Understand their role and how this fits in with company expectations
    • Have a greater understanding of their role in achieving a state of control within the company
    • Effectively discuss risk management decisions with the inspector

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