Principles of HPLC Validation


Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods, such as environmental or general chemical analyses.

This course is designed for laboratory personnel responsible for validating HPLC methods. It will also be useful for managers and quality assurance staff involved in the method validation process. For workers who develop, but do not validate methods, this class will give insight into how to develop methods that will be easier to validate. No prior experience is needed, although those with some laboratory experience will certainly benefit more than those with no experience at all.

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

NOTE:  Online payment for the course is via credit card (Stripe). Alternatively, if you would like to be invoiced directly. please contact us. Tailor-made pricing for multiple courses and/or multiple users is available upon request, including annual site licences for all LC, all GC and all LC & GC courses.