Intro
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Module 1: Introduction and late analytical method development
In this module we are building the mutual language based on the globally recognized ICH guidance and construct the mindset of laboratory professional that can connect systematically between the late stage of analytical method development and the launching of analytical method validation.
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Module 2: Specificity and Range
In this module we dive in depth into the first 2 characteristics of analytical method validation, specificity and range, to illustrate the "know-how" based on the purpose and the meaning of both.
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module 3: Accuracy and Precision.
In this module we explained the detailed process of assuring accuracy and precision taking a practical example of a simple dosage form. We illustrated how to conduct the accuracy testing, in different 2 ways and how to go through the 3 levels of precision to assure that our method is precise and finally, we sum all up to illustrate the core benefit of the course, that we have a deep, but simplified, knowledge supporting your ability to validate a reliable method.
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Analytical Method Validation Final Quiz
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