3rd AccBio / QbD Proceedings

Session: Approaches to Risk Management

Co-Chairs

Tony Mire-Sluis , Amgen

Lynne Krummen, Genentech

Presentations

04:20 PM

Development of Effective Control Strategies Using Product Quality Risk Assessment

Gregg Nyberg

04:50 PM

The Appropriate Use of Risk Management Tools in Biopharmaceutical Development

Ann Subashi

05:20 PM

The Development of a Rational Testing Strategy using QbD: A Case Study

Mary Cromwell

05:50 PM

Practical Considerations to Risk Assessments for Efficient Use in Pharmaceutical Development and Production

Christoph Stark