Hosted: Tuesday, July 11, 2017
Duration: 60 Minutes
Cryoport’s Mark Sawicki, Ph.D., chief commercial officer, hosts an informational webinar on the Quality by Design (QbD) process as it relates to logistics. QbD, a concept that has become mainstream in pharmaceutical manufacturing in recent years, integrates equipment design, logistics processes and real-time informatics.
Automating the risk management process through effective use of QbD and real-time informatics is a critical consideration when contemplating support of any commercial pharmaceutical product. Informatics that can capture and interpret data and provide automated alerts and pre-defined escalation protocols based on the nature of the data captured for hundreds if not thousands of concurrent shipments will be critical in the effective launch of next-generation therapies. QbD processes provide the foundation enabling such an approach to be effective.