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.
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:
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.
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.
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