Session: Case Studies in Technology: Design, Risk Reduction and Implementation

Successful technology transfer is an important part of the process development cycle for which there is often a large degree of uncertainty. A wide array of techniques and methods can be leveraged to assess and reduce the risk involved in transferring a process to a manufacturing plant. This session aims to highlight examples of successful methodologies and/or strategies that have been used effectively to design the process, assess risk, reduce variability or increase overall process robustness. Papers focused on sharing learnings through process development case studies are particularly encouraged This session calls for oral presentations about risk reduction or risk management during either the process technology development stage or the process application stage. For the risk reduction/management during process development stage faced by process R&D community, research works or project experience on effective risk identification and assessment, reducing time span for technology development, as well as avoiding scale-up/implementation uncertainties during every step of process development are encouraged. For the risk reduction/management during the process operation stage faced by manufacturing and operating community, the session invites studies or project experience on systematic strategy/tool development, handling of process uncertainty, or process control and operation for risk mitigation during process manufacturing.