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Xtalks, Online
2024-04-29
In the contract development and manufacturing organization (CDMO)–Sponsor relationship, the quality agreement serves to outline expectations, ensure compliance and protect both parties throughout the life of the contract. With advanced medicines such as cell and gene therapies, the living nature of the product increases the potential for the unexpected to occur. When this happens, even the slightest adversity can create contention, risking not only the program but the partnership itself. A well-written quality agreement, complete with a detailed understanding of governance, can both prevent conflict and prepare to address it should it arise.
In this webinar, the expert speakers will discuss the necessity of aligning objectives, quality standards and compliance frameworks to establish a solid foundation for a collaborative partnership. Noting the evolving regulatory landscape, they will emphasize how a quality agreement that incorporates governance policy and conflict resolution measures can help developers navigate the intricacies of compliance and adapt to regulatory changes, ultimately enhancing the agility of the partnership.
In addition to case studies that illustrate successful governance models that contribute to efficient and successful CDMO relationships, the speakers will share their experiences and best practices as well as offer an experienced perspective on effective governance and conflict resolution strategies.
Register for this webinar today to understand how a well-written quality agreement can help build efficient and successful CDMO relationships.
Keywords: Quality Control, Compliance, Partnership, Regulatory, Regulatory Compliance, CMO, Quality Assurance, Contract Manufacturing, Commercial Manufacturing, CDMO, CDMO/CMO, Quality
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Organized by:
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Xtalks |
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Invited Speakers:
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Jo Anne Valentino, VP of Quality Assurance and Regulatory Affairs at Comprehensive Cell Solutions, NYBC
Andi Baggarley, Director, Project Management at Comprehensive Cell Solutions, NYBC
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Deadline for Abstracts:
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2024-04-29
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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