Training description: The aim of the training is to present techniques used for trend analysis in output material monitoring programmes, process and product monitoring, stability testing and production environment monitoring. During the course we will discuss operating procedures to be followed in case of obtaining results not meeting the limit values, specifications and trends with examples and statistical methods used to determine control limits, detect trends and outliers. Our courses combine practical knowledge of specific aspects of the pharmaceutical sector with knowledge of data analysis methods, based on data taken from the sector. Individual statistical issues will be discussed from a theoretical perspective and later developed through exercises.
Requirements: Ability to work with a computer in the Windows environment
Training programme:
- What is the difference between results not meeting the OOS specification, the OOT trend and unexpected OOE
- What is the procedure to be followed when we obtain results not meeting the OOS specification, the OOT trend and unexpected OOE
- What are the causes and effects of process variability, product stability
- What are the process stability assessment criteria
- What methods to use to detect outliers
- What type of a control sheet to use for trend analysis
- How to determine control limits for ongoing monitoring of process and product
- How to determine control limits for ongoing monitoring of product stability
- How to determine control limits for ongoing monitoring of the environment
- How to detect a trend with the use of statistical process control
- What are the advantages and disadvantages of Shewhart, CuSum, EWMA control charts
- Descriptive statistics, graphical methods of data assessment
- Shewhart statistical control charts for measurable values
- CuSum, EWMA statistical control charts
- Statistical analysis of process capacity
- Statistical regression methods
