Foundation knowledge element of the UK Study Guide

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

  • Key topics

    What, when, where, and why we use stats in Pharma

    Pharma maths and stats, the basics

    Comparison of data, basic tools

    Graphs and charts - data analysis and trending

    Introduction to probability and confidence

    Sampling plans / Acceptable Quality Levels

    Process control and monitoring

    Correlation and regression

    Stats for qualification and validation

    Application to Annual Product Quality Reviews

  • Main Tutors

    Ilona Stezowska

  • Included

    Application of statistics to process, equipment and method validation

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

You will learn the key elements of what the Qualified Person needs to know to be able to ensure that protocols, reports and data analysis presented to them has used the appropriate statistical approach, methods, calculations and acceptance criteria.
We can't make you a statistician, we can help you spot glaring discrepancies.

  • Key statistical techniques for the Qualified Person, including:
    - Comparison of data, e.g. Correlation, student t-test etc.
    - Statistical process control, e.g. Shewhart charts, CpK / PpK
    - Trending, e.g. Regression analysis, Key Performance Indicators
    - Sampling plans, e.g. how to use ISO 2859

  • Applications of key statistical techniques, including:
    - Product Quality Reviews
    - Quality System and performance metrics
    - Sampling and testing
    - Validation and qualification
    - Storage and distribution, e.g. Temperature mapping studies
    - Determination of hold times / product shelf life
    - Process monitoring / continuous process verification

  • Key guidelines related to the evaluation of data in pharmaceutical manufacture, testing and distribution, including:
    - ICH Q1; Q2; Q8; Q11; Q14
    - GMP Annex 15; Associated Regulatory and industry guidance on validation
    - EP / BP / USP as applicable

  • Note that practical, worked examples will be included in the course to demonstrate the techniques described above
    # The majority of these can be determined in a simple excel spreadsheet

Where Are We?

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

Thank You