Integrated Solutions to Rapid, QbD-Compliant Method Development

David Walsh, LCGC North America; Dr. Daniel Prudhomme, Gilead Sciences
LCGC North America and sponsored by Waters Corporation
On Demand Webinar

On Demand Webcast Originally Broadcast by LCGC North American on September 16, 2010 at 11:00 AM EDT

Improving productivity to bring new drugs to market more quickly while reducing costs is the focus of everyone involved in pharmaceutical development. One way to make a dramatic impact on productivity is to improve the speed and output of your chromatographic method development, an activity that is performed throughout the entire drug development process. New strategies and technologies that automate the method development workflow, reduce the analysis time, and ensure that robustness is built into the method can reduce operating costs, maximize asset utilization, and improve a drug’s quality and time to market.

UltraPerformance Liquid Chromatography (UPLC) has established itself as the standard in liquid chromatographic methods and its use continues to expand into all areas of the drug development lifecycle. In addition, the FDA and ICH Quality by Design (QbD) guidances state that a best practices approach to chromatographic method development incorporates robustness into the method development process. Recent advances in instrumentation and software now allow this to be achieved in a simpler manner than previously possible.

This webcast will present an easy to use, rapid, automated approach to the development of robust, QbD-applied UPLC methods using a completely integrated method development instrument and software. It will also present case studies of its successful use.

  • Moderator: David Walsh, Editor in Chief, LCGC North America
  • Speaker: Dr. Daniel Prudhomme, Research Scientist, Gilead Sciences