Å·ÃÀAV

Course Scope

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.

In addition, this course is ideal for both practising 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.

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.

Learning Outcomes

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