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Session 8 Track A: QbD Incorporation in Large Molecule Development and Regulatory Filings
Session Chair(s)
Stephane Avella
Director, Global Regulatory Affairs, CMC Biologics
Merck, United States
Quality by Design (QbD) is no longer a regulatory initiative but an industry initiative supported by regulators. QbD approach can be applied throughout process development to enhance process and product understanding. QbD tools and principles can be leveraged to develop an effective integrated control strategy. This session will focus on practical approaches to accelerated QbD implementation and provide practical recommendations for realistic implementation of QbD elements.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand QbD principles and tools
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Understand how these tools can be applied throughout process development to enhance process and product understanding
- Understand how a control strategy can be developed leveraging the QbD tools and principles
Speaker(s)
Quality by Design Applied in Large Molecule CMC Development
Hong Li
Merck Co, INC., United States
Director
QbD Case Stories – Process Understanding for Biotech Products
Arne Staby, PhD
Novo Nordisk, Denmark
Scientific VP