Topic outline

  • The Role of the Responsible Person (RP) in GDP. Formally recognised by the MHRA

    Formally recognised by the MHRA as meeting the Training Standard and the Cogent “Gold Standard” for the role of Responsible Person (RP), this three-day course covers both the Rules and Regulations relating to Good Distribution Practice and the practical application of GDP in the workplace.


     FBE-040
     Yorkshire & Humberside, South East
     Classroom
     Role: Manager/Senior Manager, Supervisor
     Functional and Behavioural
     Sector: Chemicals, Composites, Downstream Petroleum, Explosives, Industrial Biotechnology, Medical Biotechnology, Medical Devices, Pharmaceuticals, Polymers, Signmaking

    This Course is Aimed at

    Managers, Supervisors, Technical Grades within Storage and Distribution Operations

    Overview

    Formally recognised by the MHRA as meeting the Training Standard and the Cogent “Gold Standard” for the role of Responsible Person (RP), this three-day course covers both the Rules and Regulations relating to Good Distribution Practice and the practical application of GDP in the workplace.

    This is a time of great change in the world of pharmaceutical storage and distribution, with increased regulatory focus on the risk to the patient through product temperature excursions, counterfeit and falsified products entering the supply chain plus other factors that can affect product and patient safety.

    Existing and prospective Responsible Persons, warehouse managers and supervisors, technical grades, distributors and carriers and anyone concerned with the regulatory aspects of pharmaceutical distribution will benefit from attending this course.

    Please note that the Seerpharma Responsible Person course has now been mapped to the Responsible Person Gold Standard course.

    In addition we have worked with Cogent Skills and are able to validate your training in a way that is recognised by the MHRA; providing you with the ability to give your delegates certificates which will feature the MHRA logo.

    Programme Content and Key Areas

    1. Introduction & History of GXP
    2. The Quality System
    3. Personnel
    4. Premises & Equipment
    5. Documentation
    6. Operations
    7. Complaints, Returns, Recalls & Falsified Medicines
    8. Outsourced Activities
    9. Self-Inspections
    10. Transportation
    11. Brokers (optional)
    12. Assessment

    Learning Outcomes

     The learner will:
    1. Understand the role of the Responsible Person (RP) with respect to personal responsibilities and to that of the employing company or agent and of the importance of patient and the product user safety
    2. Understand the legislation and licensing requirements applicable to the wholesale distribution of medicinal products and the role of the RP, with a particular focus on the primary responsibilities and accountabilities of the RP and their role as quality management  representative within the Supply Chain
    3. Have a clear understanding of the role of the Competent Authority for medicinal products in the licensing of the wholesale dealing of medicines and as the competent authority in the enforcement of Good Distribution Practice (GDP)  guidelines
    4. Have an understanding of the relevant role of National Organisations that also regulate the medicinal product supply chain
    5. Understand all aspects of the European Pharmaceutical directives and guidelines related to GDP for Medicinal Products and be aware of Good Manufacturing Practices (GMP) within the Supply Chain
    6. Understand and recognise best practice in Good Distribution Practice (GDP) and why this is essential in maintaining the quality and the integrity of medicinal products throughout the supply chain
    7. How to apply and maintain knowledge of how an effective quality compliance system that meets the requirements can be implemented maintained and improved
    8. Be able to identify a medicinal product, the different legal categories, storage conditions and Marketing Authorisation (MA) types such that they can be appropriately handled, stored, managed and supplied
    9. Understand the importance of applying due diligence in the discharge of his/her duties and of reporting to senior management, the competent authority and the MA holder any suspicious events of which he/she becomes aware, such as non-compliant products or the receipt or offer of medicinal products which are suspected of or identified as being falsified
    10. Understand how to review the effectiveness of an organisations quality system and implement effective corrective and preventive actions (CAPA) to address any deficiencies or non-conformance issue identified. These may include product recalls, disposal and physical segregation

    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