Amanda Guiraldelli

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Amanda Guiraldelli is scientific affairs manager at the United States Pharmacopeia.

Articles

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Evolution of Analytical Procedure Validation Concepts: Part II

Amanda Guiraldelli ;Jane Weitzel

March 15th 2023

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

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Evolution of Analytical Procedure Validation Concepts: Part I

Amanda Guiraldelli ;Jane Weitzel

March 15th 2023

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.

Latest Updated Articles

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