Statistical methods in evaluation and monitoring of product quality as per Annex 15

The scope of the training covers the guidelines of Annex 15, concerning the life-cycle approach to validation, with emphasis on the use of statistical methods of data analysis. The course combines practical knowledge of specific issues related to the pharmaceutical industry with knowledge of methods of data analysis, which are presented using data from the industry. Statistical methods are discussed theoretically and then developed in the form of exercises.

For whom?

For everyone who is involved in process validation. We invite you if you do not yet know anything about data analysis and statistics used in technological process validation lifecycle. If you already know something, but you need to organize your knowledge and go to practice. Also if you already know the statistics, but you need a tool with which you can perform your analyses quickly and easily. This course is the foundation on which you can further build knowledge and skills in data analysis.

What will you gain?

• You will get to know or systematize the basic concepts of statistical data analysis
• You will go through the stages of technological process validation
• You will learn numerical and graphical methods of data analysis
• You will get to know process stability and capability assessment
• You will receive practical tips on how to avoid errors in data analysis and interpretation
• You will learn how to plan statistical control of the technological process