Transforming Risk into Opportunity: Unlocking the Power of a Quality Risk Management Playbook

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.

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Publication Details

Journal
PDA Journal of Pharmaceutical Science and Technology
Published
2025-01-01
DOI
https://doi.org/10.5731/pdajpst.2025.25425
Primary Topic
Biotechnology and Related Fields
Type
article
Field-Weighted Citation Impact
0.00
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article

Transforming Risk into Opportunity: Unlocking the Power of a Quality Risk Management Playbook

Jerry Tischler
PDA Journal of Pharmaceutical Science and Technology
Biotechnology and Related Fields
article

Transforming Risk into Opportunity: Unlocking the Power of a Quality Risk Management Playbook

Jerry Tischler
article en

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.

PDA Journal of Pharmaceutical Science and TechnologyVol. 79(4)
Sequoia (United States) (US)
Openalex Percentile: Top 73%
Biotechnology and Related Fields
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