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Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Session Chair(s)
Holly Kleinschrodt
Head, Device & Operations Quality
Astellas, United States
Lapses in quality have resulted in CRLs, impacting approvals and threatening supply. This session will discuss enhancements to oversight by sponsors/applicants and approaches to improve collaborative problem solving across organizations.
Learning Objective : Understanding the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction; Improving contracts, agreements, and expectations between organizations for improved communication and collaborative problem solving.
Speaker(s)
Speaker
Representative Invited
FDA, United States
Speaker
Rosemary Orciari
Pfizer, United States
Senior Directory, Reg Intel, Policy and QMS Lead
Speaker
Patrick Saunders
Eli Lilly & Co., United States
Senior Director, Quality, Lilly del Caribe
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