Foundation knowledge element of the UK Study Guide

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

  • Key topics

    Contamination Control Strategy

    Microorganisms - sources, types, detection, identification, testing, removal

    Cleanroom design, validation, sterilisation, disinfection

    Product process simulations, sterility testing, preservation

    Water systems

  • Main Tutors

    Tanya Agombar (In Person)

    Greg Webber (In Person)

    _________________________

  • Included

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

By the end of this module, you will have a broad understanding of the significance of the presence of different types of microbes in pharmaceutical products and facilities, and the control measures required to prevent microbial contamination

  • How to implement a contamination control strategy
    Sources, types of microorganisms, and how to interpret monitoring data for investigations, including the hazard identification and risk evaluation related to these

  • Types of microbiological testing, including:
    # Common test methods
    # Validation of microbial methods
    # Rapid test methods
    # Endotoxin/pyrogen testing

  • Production, distribution, validation of pharmaceutical grade water

  • Production of sterile and non-sterile products, environmental controls, use of preservatives

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