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Analytical strategy and method development

Analytical strategy and method development

21 March 2023 09:00 CET

Scope

Recent regulations published by ICH (ICH Q14) and the US Pharmacopeia (USP 1220) impose new obligations on analytical method developers. Until now, this area has remained outside the regulatory sphere. The new regulations implement tools familiar from QbD into the analytical method development process. These include risk analysis, DOE or Analytical Target Profile.
The training is addressed to professionals responsible for the development of various types of analytical methods in R&D, MSAT or quality control departments.

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