Regulatory agency initiatives are changing the product development process. As a result, Quality by Design (QbD) has emerged as an approach to revolutionize regulatory submissions and post-approval supplements. A solid QbD strategy can help shorten time to market, speed approval of new products, enhance the bottom-line and increase product quality and consistency.
This session, featuring Ellen Reilly from BearingPoint, Venkat Venkatasubramanian from Purdue University, Dan Heighway from Eli Lilly and Sam Venugopal from Conformia, will explore:
- The challenge of supporting Quality by Design through information management
- The organizational impact on the management of regulatory submissions
- Knowledge management challenges between process development and the regulatory organizations
| Program Details |
|
| 7:30am -8:30am |
Networking and Breakfast |
| 8:30am -10:00am |
QbD Discussion |
| 10:00am - 10:30am |
|
Moderator
Ellen Reilly
Managing Director, Life Sciences
BearingPoint
Speakers
Venkat Venkatasubramanian, Ph.D.
University Faculty Scholar Professor,
School of Chemical Engineering
Purdue University
Dan Heighway
Manager, Product R&D IT/Automation
Lilly Research Laboratories
Eli Lilly and Company
Sam Venugopal
Director, Solutions
FDA-Conformia CRADA Co-Investigator
Conformia
Host Details:
TAP Pharmaceutical Products Inc.
675 North Field Drive
Lake Forest, IL 60045
Click Here for Map and Directions |
May 20, 2008
