The study guide emphasises that QPs must have a knowledge of the practical application of basic statistical tools in pharmaceutical production and QA. This knowledge is essential in demonstrating the capability of processes or the acceptability of materials. In particular QPs should be able to demonstrate an understanding of statistical process control, sampling
and the statistics employed during method validation. This fully revised course focuses on establishing key learning points regarding the application of techniques rather than the techniques themselves. Presentations are supported by exercises or case studies to reinforce
principles and best practices. In addition, the incorporation of ICH Q8, Q9 and Q10 into EU GMP will require QPs to be more able to understand statistical tools and techniques as part of a Quality Management System involving quality by design and risk-based approaches.
and the statistics employed during method validation. This fully revised course focuses on establishing key learning points regarding the application of techniques rather than the techniques themselves. Presentations are supported by exercises or case studies to reinforce
principles and best practices. In addition, the incorporation of ICH Q8, Q9 and Q10 into EU GMP will require QPs to be more able to understand statistical tools and techniques as part of a Quality Management System involving quality by design and risk-based approaches.
