BulletImage.pngHPLC eLearning Series

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.

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Please do contact me should you require an affordable quote for a number of users, multiple courses and or a site license for your colleagues.

Jackie Tan (jackie.tan@sepscience.com)

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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.

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

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.

Price

This full course is available for 98 USD. You will have full access to the content for 6 months from purchase. You will be able to view the modules as many times as you like, providing not only a comprehensive introductory course to HPLC, but also a valuable reference tool to refresh you knowledge as and whn required.

Registration

To start your registration / purchase process simply complete the form opposite. Once you have completed the form it will be replaced with further instructions.

 
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