Part 1: Outline and Justification for the QT Methodology

Part 1: Outline and Justification for the QT Methodology

Date: March 4, 2021
Time: 11:00AM EST
Presenter: Bernard McGarvey, Ph.D., Tech Advisor, Parenteral SC
  • Use of a standardized process versus a standardized test profile
  • Role of the sweet spot temperature TSS
  • The QT (min/max) metric
  • Analysis for dips and spikes
  • Designing the final test profiles
  • A process flowchart for the methodology

About the Speaker

bernard_mcgarvey

Bernard McGarvey, Ph.D., Tech Advisor

Parenteral SC

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 decision making and problem solving at Eli Lilly, covering both process development and manufacturing. Towards the end of his career he has applied this approach to pharmaceutical cold chain distribution leading to improvements in both the speed and quality of decision making in this area.

He currently provides technical support in the area of cold chain at Parenteral Supply Chain, Inc., https://www.p-supplychain.com/.