Gain exclusive, data-driven insights into the evolving quality and compliance landscape for contract manufacturing organizations (CMOs). Industry leaders from Thermo Fisher Scientific, Fujifilm Diosynth Biotechnologies, Boehringer Ingelheim, Simtra, and Redica Systems discuss inspection trends, common compliance gaps, sponsor–CMO collaboration best practices, and the future of quality oversight in a data-centric manufacturing environment.
As outsourcing continues to play a critical role in pharmaceutical and biotechnology manufacturing, sponsors and contract manufacturing organizations (CMOs) face increasing pressure to strengthen quality systems, improve transparency, and navigate a rapidly evolving regulatory landscape. Understanding the compliance risks that drive regulatory observations—and building effective partnerships to address them—has never been more important.
In this webinar, CMO Compliance in Focus: Data-Driven Insights and Best Practices for Sponsor Collaboration, experts from across the pharmaceutical manufacturing ecosystem come together to explore the current state of CMO quality and compliance through the lens of real-world inspection and regulatory intelligence.
Drawing on regulatory data and industry experience, the panel examines key inspection trends affecting innovator CMOs, including reinspection rates, recurring compliance challenges, and the types of quality system deficiencies that most frequently attract regulatory scrutiny. Attendees will gain a deeper understanding of common observation categories such as investigation quality, procedural adherence, quality unit effectiveness, facility conditions, and process robustness—and learn how responsibility for these issues is often shared between sponsors and manufacturing partners.
Beyond compliance metrics, the discussion focuses on what differentiates successful sponsor–CMO relationships. Panelists share practical strategies for establishing structured communication, fostering transparency, aligning expectations, and creating a culture of shared ownership for quality outcomes. The session also addresses how organizations can balance operational realities with regulatory expectations while maintaining strong, collaborative partnerships throughout the product lifecycle.
Finally, the webinar looks ahead to the future of CMO quality management, highlighting the growing importance of digital maturity, advanced analytics, integrated quality systems, predictive risk management, and real-time data sharing. As the industry shifts from reactive compliance to continuous improvement, these capabilities are becoming critical differentiators for both sponsors and CMOs.
Whether you are responsible for quality, regulatory affairs, manufacturing oversight, supplier management, or external partnerships, this session provides actionable insights to help strengthen compliance programs, improve collaboration, and proactively manage risk across outsourced manufacturing networks.
Key topics include:
– Regulatory inspection and compliance trends for innovator CMOs
– Common causes of FDA observations and repeat findings
– Shared accountability between sponsors and manufacturing partners
– Best practices for sponsor–CMO quality governance and communication
– Building trust, transparency, and operational alignment
– The role of data, analytics, and digital quality systems in future-ready compliance programs
– Emerging trends shaping the next generation of CMO quality management
Featured speakers:
– Robin Kumuluyi, Global VP Quality, Regulatory Affairs & EH&S, Thermo Fisher Scientific PSG
– Dawn Carlson, VP, Global Compliance and Regulatory Affairs, Simtra
– Helen Bickley, VP of Quality Operations, Fujifilm Diosynth Biotechnologies
– Dr. Joerg Schnitzler, VP, Head of Global Quality BioPharma, Boehringer Ingelheim
– Michael de la Torre, Redica Systems (Moderator)
Offered Free by: Redica Systems
See All Resources from: Redica Systems
