Education Details
Can Your Company Afford the Cost of Production without QbD?
Quality by Design can significantly alter the risk landscape and produce significant business benefits.
Workshops: Scalability of Design
Space ♦ Developing and Implementing an Effective Control Strategy ♦ Communicating an Effective Scientific Story ♦ Demonstrating and Maintaining a State of
Control Throughout the Lifecycle
Case Studies: A-Mab and Beyond for Monoclonals ♦ QbD for
Biologicals, A - Vax Case Study
Plenary Sessions: Regulatory Experience with Implementation of QbD ♦
Path Forward to Reconcile Regulatory Perspective
- Full Agenda (
55 KB) - Full Workshop Descriptions ( 117 KB)
Workshop Highlights
Scalability of the Design Space (Workshop 1)
- Opportunities for verification of design space boundaries at commercial scale
- Continuous process monitoring and updating design space over the lifecycle
- Design space verification with or without full scale experiments
Leaders:
- Nathan McKnight, Principal Engineer, Genentech Inc, USA
- Timothy Watson, Research Fellow, Pfizer Inc, USA
Developing and Implementing an Effective Control Strategy (Workshop 2)
- Control strategy robustness and sustainability
- Implementing the continuum of criticality
- Compare process-orientated with attribute-orientated control strategies
Leaders:
- Beth Junker, Director-BioProcess Dev, Merck & Co Inc, USA
Communicating an Effective Scientific Story (Workshop 3)
- Clear communication of product, process, and control elements
- Expectations for location and presentation of QbD elements
- Current approaches to communicating Corporate Quality Assurance, CPP, Testing
Leaders:
- Duane Bonam, Scientific Director, Amgen Inc, USA
- Vassiliki Tegoulia, Regulatory Affairs Scientist, Genentech Inc, USA
Demonstrating and Maintaining a State of Control Throughout the Lifecycle (Workshop 4)
- Pre-and Post-Approval demonstration of continued state of control
- Self-management of manufacturing control changes
- New product expectations impact on legacy products
Leaders:
- Joseph Famulare, Vice President, Genentech Inc, USA
Opening Plenary Session
Carpe
Opportunite
Regulatory Experience with Implementation of QbD: An Industry Perspective
Roger Nosal,
Pfizer, Inc., USA
US Regulatory Expectations
Steven
Kozlowski, MD, Director, Office of Biotechnology Products, FDA/OBP
Closing Plenary Session
A Path Forward to Reconcile Regulatory Perspective
Roger Nosal,
Pfizer, Inc., USA
Case Studies
- Alain Bernard, PhD, VP, BPS, UCB Pharma, Belgium
- Ranjit Deshmukh, PhD, Sr. Director, MedImmune, USA
- Lynne Krummen, Vice President, Genentech Inc, USA
QbD Conference Endorsed by CASSS
ISPE is pleased to announce its collaboration with CASSS on the QbD conference development and promotion to ISPE and CASSS members worldwide.
Headquartered in Emeryville, California, CASSS is a not-for-profit 501(c)(6) professional scientific society made up of over 4,000 industry, academic and public sector professionals.
- Conference Brochure ( 1 MB)
Thank you to our Top Tier Sponsors
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