Training course objectives
The aim of this method course is to present statistical methods for determining the running time of a product or the repeat test period of an active substance during long-term storage. The guideline Q1E of the International Conference on Harmonization (ICH) contains concrete guidelines for the statistical processing of stability data, the understanding of which will be facilitated in this seminar.
This course addresses specialists in the laboratory or quality managers in pharmaceutical companies who want to perform stability tests using statistical methods.
This course introduces the statistical procedures of the Q1E Directive for determining the life of a product. The test sequence for poolability in stability analysis is explained. The understanding of the test sequence is facilitated by flow charts.
The training consists of a detailed explanation of the mentioned procedures with generally understandable data examples from published stability studies.
Neither Statistica's knowledge of statistics nor its programme is required in this seminar. In order to fully benefit from the training, participants should be somewhat familiar with the basic concepts of stability testing.
Duration: 1 day Time: 9:30 - 17:00 h Price: EUR 800,- (plus VAT) per participant