Analytical to Clinical: Ensuring Analytical Method Validation Supports Clinical Determination
Time: 12:20 pm
day: Day One
Details:
- How to generate value added data that ensures clinical determinations and endpoint assessments are based on the analysis from a robust analytical method validation
- Define what method validation really entails and the attributes that are critical to understand
- Review the controls that are fundamental for clinical determination and the components that support validation methods
- Reflect on how to apply the Quality By Design principles in practice and provide a roadmap to pathway success
