Ann Subashi
Associate Director in Global CMC , Pfizer
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.
Anthony Mire-Sluis, Amgen
Lynne Krummen, Genentech
Greg Nyberg, Amgen
Ann Subashi, Pfizer: Appropriate Use of Risk Management Tools in Biopharmaceutical Development
Mary Cromwell, Genentech
Christoph Stark, Novartis