Approaches to Risk Management
Accelerating Biopharmaceutical Development ABD
2013
3rd AccBio / QbD Proceedings
General Submissions
Oral
Salon CD
Coronado Island Mariott
Tuesday, February 26, 2013 - 2:15pm to 6:25pm
Co-chair(s)
Mire-Sluis , T., Amgen
Krummen, L., Genentech
Talks in this session will cover the considerations and approaches for managing risk in the context of QbD principles. Talks will include identifying and assessing risk and effectively managing it through understanding CQAs and process design space. Understanding and mitigating the risk introduced by raw materials will also be covered in this session.