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Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Lapses in quality have resulted in CLRs, 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 Objectives

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.

Chair

Holly Kleinschrodt

Speaker
Patrick Saunders

Speaker
Rosemary Orciari

Speaker
Patrick Saunders


Speakers
HK

Holly Kleinschrodt

Head, Device Quality, Astellas, United States
Holly Kleinschrodt has over 20 years of experience in the medical device and pharmaceutical industry. Her experiences have included Quality Assurance, Manufacturing, and R&D. She has contributed to technologies such as implantable heart valves and rings, consumable infusion sets and... Read More →
RO

Rosemary Orciari

Senior Directory, Reg Intel, Policy and QMS Lead, Pfizer, United States
PS

Patrick Saunders

Senior Director, Quality, Lilly del Caribe, Eli Lilly & Co., United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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