Transforming Risk into Opportunity: Unlocking the Power of a Quality Risk Management Playbook: Poster Presented at PDA Week 2025.

Abstract

Navigating the complexities of compliance in the biopharmaceutical landscape-particularly for cell and gene therapies-requires innovative and effective solutions. In response to these challenges, Syner-G | Sequoia have developed a Quality Risk Management (QRM) Playbook aimed at standardizing and enhancing the adoption of quality and risk management practices across global operations. This Playbook ensures operational excellence through streamlined processes, advanced technologies, and an engaged workforce. One of the key benefits of implementing this Playbook is a transformative shift in organizational culture towards a proactive QRM approach, fostering a collective sense of quality and ownership among teams, particularly in multi-site environments. This cultural evolution not only reduces the risks associated with drug development but also redefines compliance activities by highlighting their critical role in ensuring patient safety. By embracing a practical and effective methodology to quality risk management, organizations can reshape compliance from a perceived obstacle into a strategic advantage, leading to better outcomes for the business and improved patient care. This poster will discuss how the QRM Playbook empowers teams to refine their compliance strategies and advance their drug development initiatives.