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  • Introduction to Good Distribution Practice

    Our one-day Introduction to GDP Training provides an overview into the Good Distribution Practice Guidelines, the roles and Responsibilities of the Responsible Person (RP) and the competent authorities that enforce the rules and regulations to ensure compliance when handling and distributing medicinal products.  


    Course Code FBE-053
    Region 

    UK

    Delivery Classroom
    Role Role: Laboratory, Operator, Other, Manager/Senior Manager, Supervisor, Technician
    Competence Functional and Behavioural
    Sector Sector: Healthcare (NHS), Industrial Biotechnology, Medical Biotechnology, Personal Care & Consumer Products, Pharmaceuticals

    This Course is Aimed at

    Any personnel involved in the handling and distribution of medicinal products.

    Overview

    Our one-day Introduction to GDP Training provides an overview into the Good Distribution Practice Guidelines, the roles and Responsibilities of the Responsible Person (RP) and the competent authorities that enforce the rules and regulations to ensure compliance when handling and distributing 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 any personnel involved in pharmaceutical distribution looking to obtain a general understanding of GDP and the regulations a Wholesale Distributor of medicinal products must adhere to. The course will also provide an insight into the competent authority and their role in ensuring patient safety.

     

    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.  The Role of The Competent Authority

    13.  Competency Questionnaire

    Learning Outcomes

    The delegate will:

    • Be provided with a familiarisation and understanding of Good Distribution Practice (GDP) and the Green guide;
    • Understand their role and responsibilities with adhering to the Quality Management System, operating using Good Documentation and Due Diligence Practices to ensure evidence of compliance by demonstrating traceability through good record control;
    • Understand the roles and responsibilities of the RP and the importance of their role in prevention of falsification in the supply chain and patient safety, including what can and cannot be delegated;
    • Recognise good warehouse standards and methods to remain compliant with the latest GDP guidelines and legislation;
    • Appreciate the significance of recording complaints, returns, suspicious activity and recalls effectively in relation to distribution of medicinal products and where if necessary there is a requirement to involve relevant third parties;
    • Comprehend the importance of assessing outsourced activities prior to and while trading to ensure compliance;
    • Know how to conduct regular audits of your procedures and policies, identifying areas for improvement and producing an action plan for any deviations;
    • Understand that transportation is an extension to storage and that validation should be based upon the risk of transportation route;
    • Have the opportunity to learn best practices, receive information on current trends and up and coming changes;


    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