Contract Manufacturing Quality Agreement: Defining Governance In CDMO Partnerships

Quality agreements serve a critical role within the collaborative framework of a CDMO–Sponsor partnership. For complex products, particularly those involving cell and gene therapies, unforeseen challenges can arise due to the inherent biological nature of the materials. A comprehensive quality agreement, established with a clear understanding of governance protocols, serves a dual purpose: first, by outlining expectations and ensuring regulatory compliance, it minimizes the potential for conflict. Second, it provides a mechanism for effectively addressing unforeseen issues that may disrupt the partnership or endanger the program's success.

This webinar emphasizes the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation for collaboration. Furthermore, it explores how a quality agreement incorporating governance policies and conflict resolution measures can enhance the agility of the partnership. This is particularly relevant within the evolving regulatory landscape, as such agreements equip developers with the tools to navigate compliance complexities and adapt to changing regulations.

Review case studies that showcase successful governance models in CDMO relationships as well as best practices and seasoned perspectives on effective governance and conflict resolution strategies.