Building a Qualification Program for Shipment of Vials (Cryoshipper)
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- Cryoshipper needs for a biologics in a multi-product network
- Applying Quality by Design to test shipment of vials for fleet of Cryoshippers
- Case study: Set up of the qualification program, experiences and examples
- FDA 483s lessons learned
This session is part of Cold Chain Online 2011. The first-ever online Cold Chain event - connecting the international cold chain pharmaceutical community. Learn more here.
Carolyn Williamson is a Scientist at Bristol Myers Squibb Biologics facility in Syracuse, New York since 1997. She currently is a Scientist in the Manufacturing Sciences and Technology department. Her current focus is on the validation of Freeze-Thaw processes and Shipping for biologics drug substance. Carolyn is certified as a Project Management Professional. She uses this experience in her current focused projects as well as her past experience in equipment and utility validation, mixing validation and Disposables/Consumables, including the evaluation of potential leachables in filters and bioprocess containers. Carolyn holds a B.S. degree from The Catholic University of America with emphasis in Biology and an M.B.A. degree from LeMoyne College with a concentration in Human Resource Management. She received the honor of the M&T Bank Greater Syracuse 40 Under 40 Award in 2007 and the YWCA of Syracuse and Onondaga County Amber Reilly Outstanding Service Award in 2006. Carolyn is an avid runner and is training for her 2nd Boston Marathon in April 2011.