ِAnalytical Method Validation: From Lab to Compliance, Basic level

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About Course

Course Language: Arabic / English

This course provides a structured and technically grounded basic level comprehensive illustration as per ICH Q2 guidance to Analytical Method Validation, used in pharmaceutical quality control laboratories. Delivered in three concise modules, each lesson functions as a stand-alone, data-driven video supported by scientific slides to ensure clarity and regulatory alignment. Learners will gain a solid understanding of the core validation parameters, their evaluation criteria, and practical application, The course integrates foundational concepts with real analytical examples to demonstrate how validation ensures method reliability, regulatory compliance, and decision-making based on accurate data.

To reinforce technical depth, main reference materials — including ICH Q2(R2) and additional regulatory resources — are mentioned clearly to support further professional study and implementation.

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What Will You Learn?

  • Each trainee should be able to:
  • Understand analytical method validation (AMV) as per ICH Q2.
  • Be familiar with the key references in AMV, globally (at least 3).
  • Adopt ICH guidelines as a basic reference.
  • Know the elements of AMV (at least the 4 essential characteristics).
  • Perceive the aim from each element of AMV.
  • Adopt the best practices in laboratory to achieve AMV.
  • Apply essential calculation using spreadsheet, specifically regression equation (for linearity).
  • Explain how to apply each element of AMV in the laboratory “FOCUSING ON HPLC METHOD”.

Course Content

Intro

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.

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.

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.

Analytical Method Validation Final Quiz

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