Analytical Method Validation Course
This course teaches analytical method validation for HPLC assays in regulated labs. Learners master designing studies for robustness, accuracy, precision, LOD/LOQ, and system suitability per ICH Q2(R1) and USP standards. Gain skills to interpret statistics, troubleshoot issues, and create compliant reports and SOPs for reliable release testing.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
Gain practical skills to design and validate HPLC assay methods confidently. Learn experiment planning for specificity, robustness, accuracy, precision, linearity, LOD, LOQ; apply ICH Q2(R1), USP, system suitability; interpret stats, troubleshoot failures, and develop compliant reports, SOPs, release-ready methods.
Elevify advantages
Develop skills
- Design validation experiments for compliant HPLC assays.
- Evaluate method performance including accuracy and precision.
- Calculate validation statistics like RSD and LOD/LOQ.
- Apply ICH Q2 and USP acceptance criteria effectively.
- Troubleshoot and fix failed method validations promptly.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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