Topic outline

  • Role of the Responsible Person (incorporating the Gold Standard) and GDP for Medicinal Products

    This one day intensive course is delivered throughout the UK and can also be delivered in-house. The day is very interactive and uses real examples with opportunities taken for group discussion throughout the training day. 



    Course Code COM-031
    RegionUK
    DeliveryClassroom
    RoleRole: Engineer, Manager/Senior Manager, Operator, Other, Supervisor, Technician
    CompetenceCompliance
    SectorSector: Chemicals, Downstream Petroleum, Explosives, Industrial Biotechnology, Pharmaceuticals, Polymers, Signmaking

    This Course is Aimed at

    Existing Responsible Persons, Deputy RPs, Trainee RPs, Quality Managers, Warehouse Managers & Operatives, both WDA(H) and (V) holders. Anyone needing an in-depth understanding of the requirements of a Wholesale Distribution Authorisation and Good Distribution Practice of Medicinal Products.

    Overview

    An intensive, practical, one day training course on The Role of the Responsible Person and all of the Good Distribution Practice Guidelines. The course is designed to be an enjoyable day, culminating in real learnings, applicable to each delegate’s unique working environment.

    The course covers the Good Distribution Practice Guidelines (2013/C 343/01) in detail from the Responsible Person’s perspective.

    Emphasis is placed on interaction of delegates, team activities and encouragement to ask questions and share experiences.  

    Real examples are provided throughout the training, with many examples of documentation as required by the MHRA inspectorate.

    Each delegate receives a comprehensive reference folder, complete with invaluable guidance and documentation examples, and a personalised, traceable training certificate.

    Delegates are encouraged to ask questions, both during the course and via email to the trainers in the week following the training.

    Always held in a Conference Centre of Excellence, with outstanding facilities and catering. 

    The trainers are Consultant Responsible Persons, who regularly attend MHRA inspections and are therefore in a unique position to provide information on different styles of inspectors, and very comprehensive coverage of inspections and GDP requirements.

    NB: The new Code Of Practice for Responsible Persons (published March 2016) is also incorporated into the training course.

    Disclaimer:

    * Please note that the PMN Group Responsible Person course has not been mapped to the Responsible Person Gold Standard course.

    Programme Content and Key Areas

    Introductions

    Section 1.  The regulatory background

    Section 2.  Responsible Person - Overview & Understanding

    Section 3.  Introduction to the Gold Standard

    Section 4. The Gold Standard - in detail, incorporating in depth GDP guidance

    Section 5.  MHRA Inspections & Applications

    Section 6.  Common Deficiencies & Q&A Session

    Test!

    One to one discussion with trainers.

    Learning Outcomes

    The delegate:
    • Will have a comprehensive understanding of the role of the Responsible Person; relevant legislation; the requirements of the GDP guidelines; the Code of Practice for Responsible Persons and all of the requirements of the Gold Standard for Responsible Persons.
    • Will understand the importance of the role, and how the Responsible Person ensures that the organisation is working within Good Distribution parameters, and the potential hazards which can arise from poor distribution practices.
    • Will have an understanding of the MHRA, its role and work with other healthcare providers, and particularly its work with Interpol on falsified medicines.
    • Will know how to ensure that all personnel working with medicinal products are aware of the dangers of falsified products and know how to conduct relevant checks and report any concerns.
    • Will know what a Quality Management System covering GDP should contain, and how it should be controlled and monitored.
    • Will understand the importance of correctly detailed and controlled documentation, especially Standard Operating Procedures, and of data integrity.
    • Will know how to implement risk assessment into the quality management system.
    • Will know how to prepare for, manage and respond to a GDP inspection.
    • Will understand the most common deficiencies found during regulatory inspections, and how to avoid them.
    • Will have working knowledge of the requirements introduced for the first time in the 2013 GDP guidelines.
    • Will know how to apply for a new WDA or for a Variation to an existing WDA.

    To book now contact us.
       

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