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
Presenter: John Dolan
John Dolan is considered to be the one of the world’s experts in HPLC. He has written more than 300 user-oriented articles on HPLC troubleshooting over the last 30 years in addition to more than 100 peer-reviewed technical articles on HPLC and related techniques. His three books (co-authored with Lloyd Snyder), Troubleshooting HPLC Systems, Introduction to Modern Liquid Chromatography (3rd edn), and High-Performance Gradient Elution, are standard references on thousands of desks around the world. He has taught HPLC training classes around the world to more than 10,000 students.
For a better understanding of the course format, view the first module below: