Harmonized Manufacturing Network For Sterility Assurance
Frederic Ayers at Eli Lilly and Company, Martell Winters at Nelson Labs and John Schlect at Sterigenics
About this talk
This presentation will provide an understanding related to Global Guidance related to holistic Contamination Control Strategies. The importance of cross-functional collaboration to ensure all aspects of the Contamination Control Strategies are properly applied and modified based upon appropriate feedback, including CAPA from deviations. This presentation will also discuss how to identify and drive innovation within the manufacturing space to improve Sterility Assurance processes and development of future facility and process design. Finally, this presentation will discuss how to manage regulatory interactions, which can lead to successful audits.
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