Mathematics and Statistics

Course overview

The Mathematics and Statistics (Maths and Stats), course is mapped to the UK Study guide. The learning outcomes are: 

• Understand key guidance related to the evaluation of data in pharmaceutical manufacture, testing and distribution, including:
• ICH Q1, Q2, Q8, Q11, Q14
• EU GMP Volume 4, Annex 15 and associated Regulatory and industry guidance on Qualification and Validation

Applications of key statistical techniques, including:

•   Product Quality Reviews, Quality System and Performance metrics and Sampling and testing
•   Storage and Distribution, e.g. Temperature mapping studies
•   Determination of hold times / product shelf life
•   Process monitoring / continuous process verification.

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

QPQuandary Ltd use a mixture of presentations, exercises (scenarios), and workshops to incorporate technical knowledge, leadership, and interpersonal skills to help delegates meet their aim of attaining the position of Qualified Person (QP).

Training is delivered by QPs and Subject Matter Experts from the Pharmaceutical Industry. The course is interactive, with materials, assignments and assessments provided through a learning portal. Delegates must complete pre-course work, end of day exercises and post coursework.

A certificate is issued on completion of the course and assignments.

The cost of the course is available upon request from the training provider.

Prerequisites

The course is suitable for delegates working towards the role of the Qualified Person and for existing QPs and Quality Professionals involved in manufacturing medicines, who wish to maintain Continuing Professional Development.

Additional information

The course is instructor led, with training delivered at the Maidstone Innovation Centre and online.