Foundation knowledge element of the UK Study Guide

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

  • Key topics

    Sterile dosage forms and manufacturing techniques

    Environmental controls and monitoring

    Equipment and process validation for sterile products

    Sterility testing

    Endotoxin testing

  • Main Tutors

    Alex Hall
    Tanya Agombar

  • Included

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

By the end of this module, you will have gained an overview of the key processes used to manufacture sterile medicinal products, including...

  • Major processing techniques for product sterilisation
    Factors affecting the Critical Quality Attributes (CQA) and Critical Processing Parameters (CQP) of those techniques

  • Aspects of Process validation and control of sterile medicinal products including:
    # Technology transfer and scale up
    # Aseptic Process Simulation (Media Fill)

  • Key Elements of of monitoring and control related to manufacture of sterile medicinal products, including:
    # Contamination control strategy
    # Facility design / maintenance / cleaning
    # Environmental monitoring

  • Introduction to manufacturing of Biological and Advanced Therapy Medicinal Products (ATMP)
    # See also our full course covering Biological and Advanced Therapy Medicinal Products (ATMP)

In this portal

Your materials, assignments and assessments will all be provided through this learning portal

You will be notified by email when items are available for you to access...

  • 1 month before the course start date
    ~ You can access your course workbook
    ~ You will be able to download your Preparatory Assignment

  • Day before course start date
    ~ Downloads for workshops and exercises

  • End of each course day
    ~ Answers to exercises where appropriate

  • After course
    ~ Learning assessment
    ~ Course evaluation
    ~ Certificate

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
01622 477781
email us
[email protected]
or pop your email in the box below and we will get right back to you

Thank You