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.
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
Prerequisites
This course is ideal for both practicing QPs and anyone in Production, QC or QA
Teaching provider
- Tel: +44 (0)118 918 4000
Useful information
Country: UK
Teaching method: Class/lab
Duration: 3 days
Cost: £2450.00 Plus VAT
Language: English