Principles of HPLC Validation

A short course in the systematic validation of HPLC methods

Cost: US$ 98 per user for 6 months access
What is included: 21 video modules, 21 assessment tests, Certificate of Completion

Note: the first module is free access to illustrate the value of the course

What does it cover?
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. It does not focus on bioanalytical methods (drugs in plasma or tissue). Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods, such as environmental or general chemical analyses.

Who should take this course?
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.

What do you get?
You get full access to the 21 video modules and approximately 5.5 hours of instruction.

What will I get from this course?
You will understand how to organize a validation project. By planning ahead, you will see how to develop better methods that will validate more easily and will function more reliably in routine use. You will realize how by using Quality by Design principles during development, the methods will be easier to validate and be more robust in routine use. You will learn how to decide which variables are important and which ones are not. You will see how software tools can help you to get much more mileage out of your experimental runs. You will gain a better understanding of the calibration process and how to examine data for problems. Learn when method adjustments are allowed without re-validating the method. Find out why uncertainty plays such a big role in validation.

The course was designed by John Dolan, Tom Jupille, and Lloyd Snyder. This class is taught by John Dolan, considered to be one of the world’s experts in HPLC. He has written more than 350 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 also was intimately involved in the preparation of Snyder, Glajch, and Kirkland’s Practical HPLC Method Development (2nd edn) book. John is the author of Separation Science’s popular “HPLC Solutions” articles. From a validation standpoint, he directed LC Resources’ Northwest Laboratory, a contract laboratory for the pharmaceutical industry, specializing in method development, validation, and application of HPLC methods for drug substance, drug product, and bioanalytical samples. He has taught HPLC training classes around the world to more than 10,000 students and has received the Palmer Award (Minnesota Chromatography Forum) and the Dal Nogare Award (Chromatography Forum of Delaware Valley). His casual style and ability to get information across in a practical and understandable manner make him in high demand as a training instructor and conference speaker.