Descriptif
By the end of this course, students will be able to:
- Understand the fundamental principles of analytical method validation.
- Identify and apply the main validation criteria (fidelity, accuracy, specificity, linearity, etc.).
- Design a comprehensive analytical strategy in a regulatory or industrial context.
- Master the critical steps from sampling to instrumental analysis.
- Interpret results and the uncertainties associated with analytical protocols.
By the end of this course, students will be able to:
- Understand the fundamental principles of analytical method validation.
- Identify and apply the main validation criteria (fidelity, accuracy, specificity, linearity, etc.).
- Design a comprehensive analytical strategy in a regulatory or industrial context.
- Master the critical steps from sampling to instrumental analysis.
- Interpret results and the uncertainties associated with analytical protocols.
Diplôme(s) concerné(s)
Format des notes
Numérique sur 20Littérale/grade réduitPour les étudiants du diplôme MScT-Environmental Engineering and Sustainability Management
Le rattrapage est autorisé (Note de rattrapage conservée)- Crédits ECTS acquis : 3 ECTS
La note obtenue rentre dans le calcul de votre GPA.
Programme détaillé
- Introduction to Analytical Method Validation
- Objectives and context
- Regulatory and industrial issues
- Key Steps of an Analytical Protocol
- Sampling, storage, extraction, processing
- Classic Validation Criteria
- Specificity and selectivity
- Response function and linearity
- Fidelity: repeatability and reproducibility
- Trueness, precision, accuracy
- Limits of detection and quantification (LOD, LOQ)
- Measurement range
- Specific and Advanced Criteria
- Robustness, dilution effect, stability, calibration
- Statistical Tools and Standards
- Grubbs and Cochran tests
- References: ICH Q2(R1), USP, ISO 5725, ISO 17025
- Case Studies
- Glyphosate assay in blood (LC-MS)
- Atrazine assay in salads (GC-MS)
