Approaches to QbD for Externally Sourced Deliverables

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.

Session Co-Chairs:

• Abhinav Shukla, KBI Biopharmaceuticals

• John Crowley, Lonza

Confirmed Speakers

• Lynn Conley, Biogen Idec: Using a Statistical and Risk Based Approach to Improve Robustness and Control in a Late Stage Antibody Process