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Digital Transformation Enables Review by Exception at FDI– A Case study - A "Straight from the Source" Webinar

01:29:00

Aug 6, 2019 10:32 AM

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Speakers

Samantha Schloth
Project Manager @Fujirebio Diagnostic, Inc.
Samantha Schloth is Project Manager at Fujirebio Diagnostic, Inc. (FDI) in Malvern, PA. She is leading Digital Transformation, starting with the implementation of the company’s Manufacturing Execution System and Electronic Batch Record System, spanning incoming material receipt to finished product packaging. In addition, Sam has driven the implementation of FDI’s Review by Exception approach for manufacturing batch records that has resulted in the reduction of manufacturing cycle times. To support the Digital Transformation & the implementation of new technology at FDI, Samantha has worked with the Food and Drug Administration (FDA) and her peers in Quality and Regulatory on the implementation of a Risk Based approach to Computer System Assurance. Samantha has 12 years of Life-Sciences industry experience including positions in manufacturing, purchasing, inventory &material management. Samantha earned a Bachelor's degree in Business Administration & Management from Albright College.
Daniel R. Matlis
President @Axendia Inc.
Daniel R. Matlis is President of Axendia, an analyst firm providing trusted advice to Life-Science Executives on Business, Technology and Regulatory issues. Dan has almost three decades of industry experience spanning the Health-Science value chain. He has been an active member in FDA’s Case for Quality Initiative since 2014 and has presented Axendia’s research findings to industry executives and the FDA officials. Dan began his career at Johnson & Johnson, where he provided leadership in the areas of technology, regulatory compliance and business. Before founding Axendia, Dan was a Partner, VP and General Manager at a leading Life-Science consultancy firm. He is a frequent lecturer at Industry events and has published numerous research reports and articles on key issues facing the Life-Sciences and Healthcare industries. Dan holds a BS in Electrical Engineering from Polytechnic University (now NYU School of Engineering) in NY and a MS in Management from NJIT.