Session: Risk Reduction in - and Implementation of - Process & Technology Development

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 new 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.