Session: C3: Improving Manufacturing via Modern Technology

Live Q&A (C3)

Tuesday, September 28, 2021

16:24 – 17:00 EDT

The pandemic has highlighted challenges throughout the world in ensuring continuity of operations in both the public and private sector. The use of modern technology during these times has reinforced the value of highly capable manufacturing and robust quality management. During this session we will present some of the ways modern technologies can be used to strengthen operational controls, enhance oversight and monitoring, minimize the potential for human error, and contribute to the advancement of public health. Hear from experts in the field on the potential applications of modern manufacturing technologies including isolator design, automation, and other innovative efforts. The session will also address how modern technology can be used to enhance knowledge management to the benefit of both industry and regulatory decision making.

Moderator(s)

Rebecca E. Dombrowski, MS

Supervisory Investigator, ORA
U.S. FDA
Detroit, Michigan, United States

Panelist(s)

Carl-Helmut Coulon, PhD

Head of Future Manufacturing Concepts
INVITE GmbH
Cologne, Nordrhein-Westfalen, Germany
James C. Weber

Advisor IT - Digital Manufacturing
Eli Lilly and Company
Indianapolis, Indiana, United States
David Wolton

Engineering Technology Lead
Takeda
zurich, Zurich, Switzerland

Regulatory Panelist(s)

Nicholas A. Violand

Investigator/Drug National Expert, ORA
U.S. FDA
Woodland Hills, California, United States