Mathematics and Statistics

This 3-day Qualified Person (QP) Mathematics and Statistics training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of basic statistics data analysis tools commonly used within pharmaceutical quality operations. The course meets all of the requirements of the UK Study Guide for trainee QP’s.

It is essential that any pharmaceutical quality professional has an appreciation of how to use basic statistical tools, so that data can be looked at and analysed correctly. The course includes all of the requirements of the latest UK: Qualified Person Study Guide for trainee QPs. The course is primarily aimed at trainee QPs, but will also be of great benefit to anyone who need a more detailed understanding of mathematics and basis statistical techniques.

By the end of this module, you will have a comprehensive knowledge of the main methods used to analyse data within a pharmaceutical manufacturing and testing operation.

In assopciation with QPQuandary

Dates available to book

This course is available for in-house presentation, either on-site or virtually. Please contact us for further details.

Key Topics Covered
  • The underlying principles and application of Statistical Process Control (SPC) to pharmaceutical manufacturing, testing, control processes and use in product quality reviews
  • The underlying principles and application of ISO 2859 “Sampling by Attributes” and ISO 3951 “Sampling by Variables”, including the use of sampling plans and Acceptable Quality Levels (AQLs)
  • The interpretation of stability data for modelling product performance and quality
  • Appropriate data monitoring tools used to verify that appropriate storage and distribution conditions have been maintained
  • Statistical trending methods including but not limited to the underlying principles and application of Process Control Charts, Shewhart Charts, CUSUM Charts, Pareto Analysis, process capability (Cp/CpK) and process performance (Pp/PpK)
  • Statistics used in the planning and interpretation of process, facilities, utilities and equipment validation
  • Statistics applied during analytical method validation
  • Statistical tools for comparing data sets

 

Who will the course benefit?

This course is aimed at trainee QPs as well and anyone working QC, QA and Research and Development roles who need a greater appreciation of commonly used pharmaceutical mathematical and statistic techniques.

 

Course Content

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

Pharmaceutical mathematics and statistics – the basics

Tools used for comparison of data

Graphs and charts – data analysis and trending

Introduction to probability and confidence

Sampling plans / Acceptable Quality Levels

Process control and monitoring

Correlation and regression

Statistics for qualification and validation

Application to Annual Product Quality Reviews

 

This course is run in partnership with QP Quandary.  You can book from this website or from their website.

If you are interested in booking, click on BOOK NOW above.

 

Course Cost

The cost of the Qualified Person (QP) Mathematics & Statistics training course is £2,100, plus VAT. Course will be charged in GB pounds.

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+44 1635 866699

info@inspiredpharma.com

Inspired Pharma Training Ltd,

5 Westbrook Court, Sharrow Vale Road,

Sheffield, S11 8YZ, United Kingdom.