QP mathematics and statistics

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3 Day/s

CPD Hours: 21

Classroom, online, in-house

RSC approved

Evaluation of data using mathematical and statistical techniques is a key element of controlling the quality of pharmaceutical products for human and veterinary use.


The Qualified Person must understand the derivation and application of the data with which they will be presented. This course focuses on the practical aspects of the mathematical and statistical treatment of data in the various stages of pharmaceutical manufacture and distribution.


This course does not provide detailed instruction in complex statistical techniques, rather it concentrates on the interpretation and understanding of results as they are presented to the Qualified Person and the descriptive statistics used in everyday data analysis of the Pharmaceutical Quality System.


RSC Logo Approved Training High Res (1)
This course is suitable for those individuals training to become a QP as part of a series of modules specifically designed to satisfy the requirements of the Study Guide. If you have no previous experience of the topic, then you may wish to consider attending our 1 day Interpretation of Statistical Values Used in GMP Applications course first. In addition, this course is ideal for both practicing QPs and anyone in Production, QC or QA wishing to top up their knowledge and application of various statistical tools used in the Pharmaceutical Production (including manufacturing and control) environment in a time efficient manner.<

The course includes the following topics and reinforced using group exercises:


  • Day 1
    • Review of delegates pre-course exercises
    • Standard terms and techniques including workshops
    • Trending for QPs including workshop
    • Correlation and regression including workshops
  • Day 2
    • Samples and sampling (AQL) including workshop
    • Storage & Distribution Temp monitoring / Temp mapping
    • Probability & Risk
    • Quality Risk Management - FMEA
  • Day 3
    • Comparison of Data including workshop
    • Method validation
    • Statistical process control including workshop
    • Finalise CSI Reading

    By the end of this course you will learn and understand:


    • A reminder of the basics
    • The practical application of basic statistical tools used in both pharmaceutical production and QA
    • Trending for process control and quality system oversight
    • Probability and Risk
    • Statistical sampling plans, the use of ISO2859/ISO 3951
    • The meaning of Acceptable Quality Levels (AQLs)
    • Questions the QP should ask about data collection, interpretation, integrity and analysis
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Meet the tutors

Andy Martin

A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.

Donna Connew

With over 30 years industry experience, Donna Connew has worked in stability and method development laboratories, process technology, GMP auditing, incoming materials QC, supplier quality, production QA and clinical trial QA. A QP since 2001, Donna has worked in the generic pharmaceutical industry and also as a contract auditor of API facilities.

Related course

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Interpretation of statistical values used in GMP applications course

If you book our Interpretation of statistical values used in GMP applications course, you will receive a discount of £350 (15%) off our QP mathematics and statistics course.