Approaches to QbD for Externally Sourced Deliverables
Quality Design Biologics QbD
2013
Quality by Design in Biologics (QbD Biologics)
General Submissions
Oral
Salon CD
Coronado Island Mariott
Tuesday, February 26, 2013 - 11:00am to 12:40pm
Co-chair(s)
Crowley, J., Lonza
Shukla, A., Bristol Meyers Squibb
Application of QbD principles and methods can present special challenges when working with external CRO’s, CMO’s and other external partners. This session will cover experiences and potential approaches for managing QbD application in this important interface.