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Validation – Analytical Methods

In this course, the student will learn regulatory requirements for analytical method validation. We discuss topics such as:

  • Prerequisites for method validation
  • Method types and their requirements
  • Typical validation characteristics - Specificity, accuracy, precision, repeatability, intermediate precision, linearity, range and robustness
  • Detection limit and Quantification limit
  • Reference materials
  • Experimental design
  • The validation report
  • Chromatographic methods
  • Compendial methods
  • Revalidation
  • Method transfer
  • FDA 483's and warning letters
Tthe course allows for plenty of discussion and questions.