09.00 – 09.15 h
Introduction
09.15 – 09.45 h
Regulatory Importance of Trend Analysis
- Expectations
- Process capability and performance
- Regulatory references
- Future requirements
09.45 – 10.30 h
An Introduction to the Statistical Tool Box; Distribution of Data and its Characterisation
- Specifications and processes
- Data types and models
- Populations and samples
- Data distributions
- Errors and confidence intervals
10.30 – 10.45 h
Questions & Answers
10.45 – 11.00 h Break
11.00 – 12.00 h
Trending for Process Control of Variables
- Statistical Process Control
- Individual and moving range charts
- Process capability indices
- CUSUM & EWMA charts
- Investigation using CUSUM
12.00 – 12.15 h
Questions & Answers
12.15 – 13.15 h Break
13.15 – 13.55 h
Workshop 1 on Variables
- SPC of continuous individual and grouped monitoring data using the moving range and mean and range methods
- Interpretation
- Conclusions
13.55 – 14.15 h
Feedback from Workshop 1
14.15 – 15.15 h
Trending for Process Control of Attributes
Basic differences between attributes and variables
Distributional requirements
AQLs & sampling for attributes [OOE attributes with a batch]
Control charts for attributes; an overview
15.15 – 15.30 h
Questions & Answers
15.30 – 15.45 h Break
15.45 – 16.25 h
Workshop 2 on Attributes
ATP bioluminescence is used to provide a rapid and simple method to monitor the microbiological cleanliness of a process plant at a Critical Control Point (CCP). The data, in the form of discrete Relative Light Units (RLU), measure the amount of microbial ATP.
- Interpretation
- Conclusions
16.25 – 16.45 h
Feedback from Workshop 2
16.45 – 17.00 h
Overall Questions & Answers Session
17.00 h End of training