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#327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Wednesday June 18, 2025 10:30am - 11:30am EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-633-L04-P; CME 1.00; RN 1.00

Perceived and real lapses in Manufacturing Quality have resulted in CRLs, impacting approvals and threatening supply. This session will discuss issues and opportunities to enhance oversight and communication by sponsors/applicants and approaches to improve collaborative problem solving across organizations.

Learning Objectives

Discuss the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP and submission issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction, application of the Quality Management Maturity model, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker

Speaker
Rosemary Orciari

Speaker
Patrick Saunders


Speakers
avatar for Holly Kleinschrodt

Holly Kleinschrodt

Head, Device & Operations 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 →
avatar for Rosemary Orciari

Rosemary Orciari

Senior Director, Reg Intel, Policy and QMS Lead, Pfizer, United States
Rosemary Orciari is the Senior Director of Regulatory Intelligence and Quality Standards at Pfizer, Inc. In this role, she is responsible for enabling quality and compliance excellence to support breakthroughs that change patients' lives. Together with her team, Rosemary actively... Read More →
avatar for Patrick Saunders

Patrick Saunders

Senior Director-Quality, Lilly del Caribe, Eli Lilly & Co., United States
Patrick A. Saunders currently serves as the Sr Director - Quality at Lilly del Caribe in Carolina, Puerto Rico. Patrick is a seasoned professional with nearly two decades of experience in the pharmaceutical industry. His expertise spans across both parental and oral solid dosage drug... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
143ABC 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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