Challenges of Development—Anticipating Your Process
George P. Millili, PhD, Senior Principal Technical Advisor, Compliance, and External Collaboration, GENENTECH will kick off the Tech Transfer sessions in Track 1 at 13.00 today. These sessions are designed to focus on Proactive Scale-up and Technology Transfer Practices. Millili will discuss the principals of manufacturing science and robustness and the goals of scale-up and technology transfer.
“Industry challenges include leaner R&D pipelines, pricing pressure, growing expectations from global regulatory agencies and pressures for increased speed to market,” says Millili.
Stop by the Peale room on the first floor after lunch to hear his presentation. The track also includes:
- FDA Moderator: David Doleski, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/DGMPA
- Dora Kourti, PhD, Senior Technical Director, GSK – Role of PAT in Quality/Technology Transfer
The track continues after the networking break at 15.00 with a focus on Knowledge Management. Marty Lipa, Executive Director, Merck Manufacturing Division and Rob Guenard, PhD, Merck Manufacturing Division, will discuss “knowledge flow,” including strategy development that connects business and customer needs to improved knowledge flow and a Knowledge Management (KM) program that has delivered value to Merck.
“Knowledge Management enables the pharmaceutical quality system across the entire product lifecycle,” says Guenard. “The keys to sustainable and effective KM are people, technology, process and content. All four elements of the construct – People, Process, Content, and Technology – have to be addressed in a balanced manner.
Claudia Lin, Berkeley Site Head, QA-Dev, Bayer will also speak during the session on How Process Monitoring Feeds into Knowledge Management.
The Knowledge Management part of the afternoon will take place in the Holiday Ballroom.
Find out more information about afternoon the schedule in the Onsite Guide.