Delaware BioBreakfast

“Realizing Quality Benefits from Technology”

Featured Speaker:
Saroj Patnaik
Executive Director
ILC Dover

As defined by ICH 10, the Pharmaceutical Quality System shifts quality from a reactive approach to a proactive one. In the PQS, to fully realize a product’s potential, one must establish and maintain a consistent state of control and incorporate continual improvement throughout the product lifecycle. In addition, the new manufacturing model demands cost-effective innovation to control contamination and potent exposures, all while maintaining a smaller foot print facility, capable of manufacturing as many drug products for a smaller patient population. All of this makes product change-over expensive. As a solution, imagine process equipment designed to control both contamination and exposure and to achieve product realization faster, even cheaper while complying with PQS. The session will present an innovative technology solution that caters to this new demand of the industry.

For more information:
Denée Crumrine
denee.crumrine@delawarebio.org
302-452-1104

Location:
Delaware Biotechnology Institute
15 Innovation Way
Newark, DE 19711