Principles of HPLC Validation

This class focuses on validating high-performance liquid chromatographic (HPLC) methods developed for the analysis of pharmaceutical drug substance (pure drugs), drug product (formulated drugs), impurities, and degradation products. Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods, such as environmental or general chemical analyses. Here’s what the course covers:
  • What the steps are that need to be undertaken during validation
  • Why quality is so important
  • What basic chromatographic measurements will be used
  • Why to approach validation as part of a larger process
  • Which regulatory documents are important
  • What parameters of the method need to be tested
  • What are the different standardization techniques, and when are they used
  • What is Quality by Design, and why is it important
  • What software tools are available to simplify the process
  • What pitfalls should be avoided in validation
  • What is pre-validation, and why is it worth my time
  • How do I choose a system suitability sample
  • How can I tell if the method is out of control
  • How much can I adjust a method before I have to re-validate

For a better understanding of the course format, view the first module below:

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