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



VenueOnline Event, USA - United States USA - United States

KeywordsQbD Approach; Lifecycle Approach; Guidance Documents


Topics/Call fo Papers

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

Last modified: 2019-03-15 18:09:11