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HPLC Analytical Method Development and Validation


London, UK (November, 27 - 28, 2012)

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications.

This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development.

Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines.


Who Should Attend?

Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories.

Managers with a responsibility for generating regulatory submissions.


Course Programme:

Day One

  • Analytical method development, part 1
  • Workshop: Selecting the separation mode
  • Analytical method development, part 2
  • End of Day One: Group discussion


Day Two

  • Developing stability-indicating methods
  • Workshop: Developing stability-indicating methods
  • Validation of chromatographic methods, part 1
  • Workshop: Validation of chromatographic methods
  • Validation of chromatographic methods, part 2

More: http://www.pharma-training-courses.com/hplc-analytical-method-developm

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