Dr Rainer Gnibl, GMP Inspector for EMA
Prof Edwin van den Heuvel, University of Technology Eindhoven
Dr Andreas König, Quality König
Dr Jens-Uwe Rengers, JeRo Consulting
Aline Zillig, Kite Pharma
This pre-course session will provide you with recommendations, tools and examples to apply statistical principles in your day-to-day business and it will help you to meet future challenges.
You will gain understanding of the consequences of appropriate and inappropriate performance parameters and a sound evaluation of data also by working with statistical simulation tools.
This Education Course is designed for managers, supervisors and all other staff members in the pharmaceutical and API industry who are involved in preparing and compiling Quality Reviews and Metrics.
The Application of statistical Tools in Data Review
- Ongoing/data collection and management
- Interpretation, comparison and presentation of data
- Describing process capability and Performance
- Control Charts; what is a trend and how to deal with it?
- Quality Metrics
- Documenting the outcomes; are we in control?
- Quality Review Summary Report
- Descriptive statistics
- Outlier detection
- Normality testing
- Quality Review Performance
- Control Charts
- Capability indices
The Session includes a Workshop with a statistical Software to explain and understand: What are the Data telling us?
A case study on analysing and interpreting process Performance data.