Engineering First Principles: Applications to Pharmaceutical Manufacturing


05th November 2019 | 10.00 am EST | Bernard McGarvey, PhD Chemical Engineering |BOOK FREE SEAT

Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy many problems will be encountered that need to be solved. The use of a First Principles based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles based approach will be presented. Finally an example of the application of First Principles in the pharmaceutical industry will be briefly described.

Presented by Bernard McGarvey, PhD Chemical Engineering

Bernard McGarvey retired as an engineering fellow at Eli Lilly and Company at the end of 2017. He has a B.E. and Ph.D. in Chemical Engineering from University College Dublin, Ireland. He spent 34 years working for Eli Lilly and Company at various locations in Ireland and the USA. He has held a variety of roles in process control and process engineering over this time, as well as time in corporate manufacturing. His main interest is in the application of First Principles thinking to improve engineering (and management) decision making and problem solving at Eli Lilly, covering both process development and manufacturing. Over his career he has completed projects in all the various types of pharmaceutical operations – API, fill finish, medical devices, and animal health. Towards the end of his career he has applied First Principles based approaches to pharmaceutical cold chain distribution leading to improvements in both the speed and quality of decision making in this area at Lilly.


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