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Xtalks, online
2023 -9-13
In this webinar, the featured speaker will highlight the path to process efficiency and risk mitigation, in compliance with Annex 1 for the design and control of biomanufacturing facilities, along with a plan for integrating the Contamination Control Strategy (CCS). Contamination control plays a pivotal role in safeguarding biomanufacturing processes, and the revised Annex 1 regulations highlight the importance of implementing a comprehensive CCS rooted in Quality Risk management (QRM) principles.
The featured industry expert will share the value of a robust CCS. Attendees will discover how to proactively identify, scientifically evaluate and control potential risks to quality, ensuring that operations are optimized for success. In addition, attendees will discover how to calculate risk and establish mitigation strategies for high-risk scenarios. Participants will learn how to define critical control points and assess the effectiveness of design, procedural, technical and organizational controls and monitoring measures. The speaker will share invaluable insights into the six key focus areas that drive a successful CCS. This webinar presents a unique learning opportunity to establish risk elements through a meticulously planned strategy of identification, leveraging industry-proven assessment tools.
Register now to unlock the potential of a well-planned CCS and address contamination control practices that can help transform a facility’s performance and take biomanufacturing operations to the next level.
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Organized by:
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Xtalks |
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Invited Speakers:
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Jeff Odum, CPIP, Practice Lead, ATMPs and Biologics, Genesis AEC
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Deadline for Abstracts:
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2023 -9-13
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Registration:
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Free registration
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E-mail:
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ajuurinen@xtalks.com
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