CRED Getting the CMC Dossier Right 2024

28/08/2024

Control of Active Drug Substances

Bethany Jackson

Associate Principal Scientist

Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Objectives

⚫ Regulations and Guidelines

⚫ Critical Quality Attributes and Specifications

⚫ Analytical Methodology and Validation

⚫ Reference standards

The Organisation for Professionals in Regulatory Affairs

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