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In this session, our speakers present an introduction to chromatographic validation. The session will consider topics such as why validate a chromatographic method, regulatory guidelines, eight steps of analytical method validation and a review of how and when to use statistical tests. A must see for everyone working in a regulated environment requiring validated methods or those wishing to benefit from the increased confidence that method validation brings. 


Topics include:

  • The method validation process
  • Guidelines on implementing analytical method validation (AMV)
  • Analytical performance characteristics - accuracy, limit of detection, limit of quantification, specificity/selectivity, linearity, range, robustness
  • Statistical tests used in AMV