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  • GDP Responsible Person Cogent “Gold Standard” Training formally recognised by MHRA

    This course has been mapped to the Cogent Gold Standard and is 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 fulfils the training requirements of Chapter 2.2 of the Good Distribution Practice (GDP) guidelines. Our course evaluates the roles and responsibilities of the RP in relation to current legislation for GDP for medicinal products.


    Course Code FBE-056
    Region 

    UK

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

    This Course is Aimed at

    Existing and potential Responsible Persons, Pharma Managers and Supervisors, Key Quality Assurance Team Members, Managers and Supervisors, Key Team Members involved in the storage and distribution of medicinal products.

    Overview

    This course has been mapped to the Cogent Gold Standard and is 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 Cogent “Gold standard” Responsible Person (RP) Training, formally recognised by the MHRA, fulfils the training requirements of Chapter 2.2 of the Good Distribution Practice (GDP) guidelines. Our course evaluates the roles and responsibilities of the RP in relation to current legislation for GDP for medicinal products.

     

    The pharmaceutical industry is a highly regulated sector where the paramount focus on minimising the risk to patient safety has led to significant changes in recent years.

     

    The course would be beneficial for existing and potential RPs, Pharmaceutical Managers or personnel involved in pharmaceutical distribution looking to expand their GDP knowledge.

     

    We firmly believe that the success of your business and compliance with GDP is in the hands of your RP.

    Programme Content and Key Areas

    1.    Introduction

    2.    Quality Management

    3.    Personnel

    4.    Premises & Equipment

    5.    Documentation

    6.    Operations

    7.    Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls

    8.    Outsourced Activities

    9.    Self-Inspections

    10.  Transportation

    11.  Brokers

    12.  Licensing, Authorisations & How The Industry Is Regulated

    13.  Due Diligence of Suppliers & Customers

    14.  Medicine Classifications

    15.  The Role of the Professional Bodies That Regulate Those Supplying Medicinal Products

    16.   Assessment

    Learning Outcomes

    The delegate will:

    • Understand their role and responsibilities as a named Responsible Person on a Wholesale Distribution Authorisation (WDA) and their accountability role in the legitimate supply chain;
    • Discern how complying with the European Guidelines and UK legislation will ensure control of the distribution chain to prevent Falsified Medicines from entering the legal supply chain. Consequently, maintaining the quality and integrity of medicinal products and reducing the risk to patient safety;
    • Recognise the different roles and responsibilities carried out by the competent authorities and professional bodies who regulate different members of the supply chain to ensure patient safety, regulation enforcement and prevention of falsification;
    • Be provided with an overview of the wider scope of legislation and regulations involved with protecting the supply chain, from Good Manufacturing Practice (GMP) to the regulations of supply to the end user;
    • Comprehend the importance of an effective quality system which enshrines the requirements of the legislation and regulations to protect their participation in the supply chain of medicinal products;
    • Understand their role in implementing and maintaining Good Documentation Practice and Good Due Diligence Practice whilst fulfilling their duties personally and as an organisation carrying out a GDP activity. Thus, ensuring evidence of compliance demonstrating traceability through the system minimising the risk of falsification and unsafe practices;
    • Understand the role the RP plays, as a member of supply chain, in preventing falsification and in the event of suspicious activity the importance of informing the relevant third parties and assisting where necessary;
    • Establish the vital role outsourced activities carry out on the company’s behalf and the importance of documenting the role and responsibilities of subcontractors and ensuring the continuous assessment to prevent uncontrolled practices;
    • Recognise the continuous changing dynamic of a pharma business, external influences and the requirement to analyse, assess, control and review the effectiveness of the processes carried out. This allows the RP to identify good practices, training requirements, areas of non-conformance or improvements to enable continuous compliance.
    • Have the ability to assess the products intended for GDP activity, including but not limited to; their product category, temperature requirements, storage conditions and handling requirements as outlined by the product specifications and Marketing authorisation type to ensure they are handled safe and effectively in line with GDP.


    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.