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Amanda Guiraldelli
Articles
Evolution of Analytical Procedure Validation Concepts: Part II
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) , and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
Evolution of Analytical Procedure Validation Concepts: Part I
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.