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  • GDP Audit Training

    Our one-day GDP Audit Training provides an overview into best practices when conducting an Audit of a third-party site or Self-inspection of own site in relation to Good Distribution Practice (GDP).



    Course Code FBE-055
    Region 

    UK

    Delivery Classroom
    Role Role: Laboratory, Operator, Other, Manager/Senior Manager, Supervisor, Technician
    Competence Functional and Behavioural
    Sector Sector: Healthcare (NHS), Industrial Biotechnology, Medical Biotechnology, Personal Care & Consumer Products, Pharmaceuticals

    This Course is Aimed at

    Any personnel conducting audits internally or as part of a third party verification process.

    Overview

    Our one-day GDP Audit Training provides an overview into best practices when conducting an Audit of a third-party site or Self-inspection of own site in relation to Good Distribution Practice (GDP).


    This is an interactive one-day course designed for people who want to achieve an understanding of the audit process. Whether you work to GDP or ISO standards, it is a requirement that audits are carried out either internally or at the premises of your key suppliers to confirm compliancy.

     

    The role of the auditor is not only to confirm compliancy but is key to the improvement of processes across the company.

     

    Internal or external process audits should be planned and carried out by trained personnel with a sound audit knowledge to enable them to determine the effectiveness of the quality system against the standard or directive or to the procedures in place.

    Programme Content and Key Areas

    Course Objective:

     To deliver knowledge in how to plan, perform and report the outcome of an audit in order to assess internal or external compliancy relating to product integrity or quality systems. To be able to contribute towards continual improvement.

     

    Key areas include:

    •  An overview of Quality Systems and the 8 principals
    • Plan, Do, Act, Check quality management principal
    • An overview of Risk Assessment & Change Management
    • Training and workshops on how to plan, perform and report the findings of a process audit
    • Non-compliance reporting
    • CAPA and CAPA review


    Learning Outcomes

    The delegate will:

    •  Understand the significance of assessing the effectiveness of the quality management system, processes and personnel to maintain compliance;
    •  Be able to plan, perform and construct an audit report using best practices;
    •  Be able to critically assess key processes for non-compliance, conformity and areas for improvement;
    •  Know how to grade non-conformance and document corrective and preventative actions;
    •  Have the opportunity to learn best practices, receive information on current trends and up and coming changes.


    To book now contact us.

       

    Contact Us

     01325 740900

     Send us an enquiry


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