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PROGRAM:
1. General applicable concepts; concept, objectives, ICH Q2 regulations, qualitative methods, quantitative methods and validation parameters.
2. Validation for a quantitative parameter.
Accuracy, precision, linearity, range, quantification limit and robustness.
Strategies for method validation: standardization of areas, addition of known standards…
OOS applicable to the validation of a method.
Quality specification and revalidation.
3. Types of strategies for developing a method: when a method does not need to be validated.
Methods applicable to forced degradation studies and determination of impurities.
Characteristics of a sample for it to be representative.
4. Calibration of measuring instruments and qualification of devices, equipment and systems.
Standard or pattern and different typologies: primary-secondary patterns, certified-non-certified patterns, etc.
5. Relationship between traceability and the use of a pattern.
Associated statistical calculations.
6. Methodological error and types.
Validation protocol for an analytical method and associated documentation.
Statistical calculations associated with parametric results.
7. Accuracy and selectivity.
Possible non-compliances in the validation of an analysis method.
8. Accuracy, range, linearity, quantification limit, detection limit.
Potential breaches in the validation of an analysis method and retrospective testing.
9. Validation of both qualitative and quantitative microbiological methods.
Specific specifications only applicable to this methodological typology.
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