Topic outline

  • Responsible Persons

    The 2 day course is aimed at RP’s, Deputy RP’s or those planning to become an RP.  Based on the Gold Standard, and gives a practical understanding of the key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence.

    Course Code FBE-057


    Delivery Classroom
    Role Role: Laboratory, Operator, Other, Manager/Senior Manager, Supervisor, Technician
    Competence Functional and Behavioural
    Sector Sector: Pharmaceuticals

    This Course is Aimed at

    RP’s, Deputy RP’s or those planning to become an RP.


    This intensive 2-day course evaluates the key roles and responsibilities of the Responsible Person (RP) and Deputy RP in relation to Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C343/01 and the latest requirements included in the MHRA Orange/Green Guides.

    Programme Content and Key Areas

    The course is currently going through the Cogent Skills mapping process of meeting the Training Standard and the Cogent "Gold Standard" for the role of Responsible Person (RP). 

    Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required to operate and fully meet regulatory requirements.

    Offering a practical explanation of the guidelines for those implementing GDP, as well as those involved in the management of quality.

    Learning Outcomes

    By the end of the course you will:

    • Understand what your key responsibilities are as an RP and or Quality Champion
    • Have a clear understanding of your key responsibilities and accountabilities with a clear focus on the legal and compliance aspects
    • Have a comprehensive understanding of the MHRA/EU Regulator expectations and how to address and correct actual deficiencies
    • Be familiar with latest GDP guidelines as covered by EU directives/regulations and guidelines (including the Green and Orange Guide)
    • Understand how to establish and maintain bona fides for all your suppliers and customers, and the compliant management of supply chains
    • Have detailed knowledge on the best in class standards of GDP and why is it so essential for patient safety
    • Appreciate the dangers and challenges posed by falsified products

    To book now contact us.


    Contact Us

     01325 740900

     Send us an enquiry

    If you would like to book onto this course or would like any further information please contact Karen McCallum on 01325 740900