Foundation knowledge element of the UK Study Guide

What the QP needs to know and how it all works in practice

  • Key topics

    QP Legal and Routine duties

    GMDP - QP responsibilities

    Import / Export

    QP Declarations for API and IMP

    Obligations of authorisation holders

    Complaints, recalls and investigations

    QP batch disposition

  • Main Tutors

    Mike Halliday

    Helen O'Shea

  • Included

    Regulatory considerations

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

By the end of this module, you will have a comprehensive knowledge of how to fulfil the Qualified Person role in the ever changing world of pharmaceutical manufacturing and distribution.
There are many different roles a QP can undertake, sometimes being a specialist such as auditing or troubleshooting for many products, sometimes covering the entire lifecycle and supply chain for a single product.
Our course is designed to show you the breadth of the role and give you the tools needed in your future career.

  • Regulations and guidelines essential for the Qualified Person, including:
    - Good Manufacturing and Distribution Practice (GMDP)
    - UK and EU/EEA legislation / guidelines
    - Global and regional legislation / guidelines e.g. PIC/s, ICH, FDA etc

  • The specific requirements related to the position of the GMP Qualified Person as defined in UK, EU/EEA legislation, including:
    - Annex 16 and other specific elements, e.g. Annex 21
    - UK QP Study Guide and Code of Conduct
    - The role of the QP in regulatory inspections and their relationship with holders of Manufacturing and Marketing Authorisations

  • The obligations of the Qualified Person in the oversight of the Supply Chain and Pharmaceutical Quality Systems
    - With practical advice on how to appropriately delegate whilst maintaining oversight

  • Key interpersonal skills for the QP

How to find us:

Location: Maidstone Innovation Centre Gidds Pond Way,Weavering, Maidstone, Kent ME14 5FY

Maidstone is very accessible by car, with the M2 and M20 motorways providing easy connections to the M25.

Southeastern run trains across the county and Maidstone town centre benefits from two railway stations. Maidstone East connects to London and Ashford, while Maidstone West links to Gatwick and Tonbridge.
how to find us

Want to know more, find out about the discount bundles available, or book your training

Call us directly on
07521 219381 (tue - thur)
email us
[email protected]
or pop your email in the box below and we will get right back to you

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