About the Laboratory Method Validation - Foundational Course

Learn the essential principles of laboratory method validation in the pharmaceutical industry. This course provides a structured overview of how to validate analytical methods to ensure accuracy, reliability, and reproducibility in line with FDA, EMA, and ICH guidelines. You’ll explore key validation parameters—such as precision, specificity, and robustness—and walk through the step-by-step process of developing a validation plan. The course also covers risk management strategies, documentation best practices based on ALCOA++ principles, and fundamental data analysis techniques to support regulatory compliance. Case studies and skills-based exercises help reinforce your learning with practical examples. Whether you’re new to pharmaceutical analysis or need a refresher on current validation practices, this course will strengthen your understanding and readiness for real-world applications.