Module 3 Presentations

07/05/2024

Analytical Procedures and Validation

Speaker: Jorge Colmenares Contributors: George Vine, Sebastien Huyghe

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes – In this presentation we will cover

• Types of analytical procedures and validation • Method activities at various stages of development • The Validation Process as part of Life cycle • Validation parameters for Drug Substance Assay • Additional Parameters for Drug Substance Impurities • Emerging Approaches: QbD for Analytical Procedures

The Organisation for Professionals in Regulatory Affairs

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