Approaches to Risk Management

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.

Session Co-Chairs:

• Anthony Mire-Sluis, Amgen

• Lynne Krummen, Genentech

Confirmed Speakers

• Greg Nyberg, Amgen

• Ann Subashi, Pfizer: Appropriate Use of Risk Management Tools in Biopharmaceutical Development

• Mary Cromwell, Genentech

• Christoph Stark, Novartis