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2023 Aseptic Conference

ses202c - Human factor control strategy in cell & gene production

‐ Mar 7, 2023 12:30pm

Advances in developing new therapies require enhancement in training methods. This presentation will address the lessons learned by applying the Meta-EA (Meta Error Analysis) risk profiling and mitigation approach in cell and gene therapy manufacturing processes. Unlike traditional risk analysis approaches, Meta-EA is able to create a differentiated objectifiable risk profile of the process by a frame-by-frame assessment of potential /error, including objectifiable risk assignments. Based on this risk profile, it’s possible to identify risk clusters and quantify the individual risks of the different failure types in relation to the overall risk. In addition, the underlying data set enabled the creation of a blueprint to map key mitigation actions to the process risk profile and design and justify targeted initiatives to control key risk clusters. As part of the mitigation, a Virtual Reality Simulator is used to subsequently train and monitor employees on targeted behaviours to avoid previously identified critical errors, thus training them to become "prepared on critical risk". Key to this is an automated feedback system generated by the VR-Simulator, which identifies individual blind spots and behavioral weaknesses related to the associated risk profile, thus improving human reliability in executing tasks with the highest criticality.


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