Course Description

The introduction of the EU requirement for Product Quality Reviews, ICH Q8, Q9, Q10 and Q11, and new guidance from both the FDA and EU on Process Validation, which includes ‘continued process verification’, all mean that the Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide and the vital information that can be obtained by trend analysis. This module assumes that delegates have little or no experience in the application of statistical techniques and will demonstrate how simple statistical tools can be used to turn data into useful information.

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