The validation of analytical methods is of great importance in regulatory affairs. Therefore the basics of statistics are necessary to ensure the efficient validation of methods and the control of the measurement parameters. This seminar provides by avoiding high math a practical easy-to-understand approach to statistic parameters which are indispensable in connection with typical validation specifications.
The first day of the seminar deals with specific terms of statistical terms and validation processes. The requirements of a validation are as well presented as its limitations. The mathematical tools are then demonstrated in examples and can be applied in case studies. For achieving an improved comprehension of validation parameters and their application the seminar provides specific examples on the second day. The individual elements of validation will be discussed in detail. If desired, the own validation SOP could be part of the discussion.
- The Validation parameters – what should, what could, how and when be validated?
- Precision, accuracy of the mean, accuracy – what is he difference? Which RSD-value is “good” enough?
- How to perform validations from a practical point of view?
- Calibration/Linearity – not such a “common” issue…
- Which reference of the authorities is a „must” how much “freedom” is possible and last but not least: When is a re-validation necessary?
2th Day: „evaluation of the results, typical mistakes and errors during validation“
- Is this a variation or an outlier?
- Which criteria are common but hardly feasible?
- Why are there problems in daily work even with validated methods?
- Teamworking on different analytical situations and case studies
- Trends and recommendations for a contemporary validation practice
- The seminar is designed for application specialists in analytical laboratories who perform chromatographic method validations.