Topic outline

  • Responsible Person Refresher

    A one-day course presented by former MHRA inspectors. The agenda will address those areas the Responsible Person typically finds difficult to implement. A key focus will be maintaining the integrity of the supply chain. The course is not a re-cap of GDP but an opportunity to expand the skill-set.
    Course Code COM-058
    Region

    UK
    Delivery e-Learning
    Role Role: Other, Manager/Senior Manager, Supervisor
    Competence Compliance
    Sector Sector: Healthcare (NHS),  Pharmaceuticals

    This Course is Aimed at
    The Training Course is of particular interest to the experienced Responsible Person; but is also suitable for other Quality Personnel and Supply Chain Personnel. 

    Overview

    The Responsible Person must keep up-to-date with their knowledge and experience. This can be particularly challenging in a pressured work environment. The course will provide opportunities to meet those challenges and the ‘difficult to implement’ areas by tapping into the experience of the former MHRA inspector. The activities are intended to focus on carrying out the role effectively and in demonstrating compliance to the inspector.

    Programme Content and Key Areas

    • A focus on licence holder obligations and RP authority and responsibilities
    • Demonstrating continued knowledge and experience to the inspector
    • Defining the scope of outsourced activities and ensuring effective control
    • Understanding product types to engage all staff in the fight against falsified medicinal products
    • Practical applications of data integrity within GDP

    Learning Outcomes

    • The Responsible Person will be more confident in implementing activities that are not well described in GDP but are compliance expectations.
    • The Licence Holder will be able to demonstrate meeting the requirements of Regulation 45.
    • Learners will have the opportunity to discuss their learning with other industry professionals.
    • All course attendees will have the opportunity to ask questions from former MHRA inspectors – in relation to the course material, or in more general terms, relating to the wholesale of medicinal products.


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