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BioProcess International
Delivered as a Hybrid Event
September 18-21, 2023Boston Convention and Exhibition Center

Jeffrey Baker
Senior Fellow, NIIMBL, Senior Strategy Advisor of CBI, MIT at (former Deputy Director, Office of Biotechnology Products, CDER, US FDA)

Agenda Sessions

  • KEYNOTE ADDRESS: “It’s OK, the stuff we want you to do hasn’t been done before”: Stories from a Century of Insulin Manufacturing

  • It has been well posited that adults learn best through memorable experiences. Effective blended learning programs provide relevant experiences in low risk environments and can be used to anticipate and frame learning needs rather than scavenging learning opportunities from unplanned events. This course is intended as an example of using interactive simulation gaming as a tool for blended learning, specifically introducing participants to the routine and unanticipated elements of operating a biopharmaceutical manufacturing facility. In this session we will touch on elements of capacity and throughput management, statistical process control, quality culture, assignment of roles and responsibilities, and examples of the cost vs value conundrum confronted by manufacturing site governance. Attendees will be participating in a Learning Laboratory experience that is not compatible with coming and going during the session, doing email on your phone, or bailing out when an in control and capable process with fully gaussian outputs, little if any special cause variability, and a very accommodating and flexible management team suddenly goes awry!

  • SBR-1 Workshop Continued


Speakers at this event