2019 - QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

Introduction: Using a Lifecycle Approach for Analytical Procedures
Stage 1: Method Design, Development and Understanding
Using an Analytical Target Profile to Guide Development
Case study
Using QbD Principles to Explore the Method Operable Design Space
Case study
Stage 2: Method Qualification
Integrating Validation, Verification and Transfer
Case study
Stage 3: Method Performance Verification
Using Change Control and Risk Assessment
Case study
Questions and Discussion