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Digital Transformation Enables Review by Exception at FDI– A Case study - A "Straight from the Source" Webinar
Review by Exception is the ultimate goal of Electronic Batch Records (EBR) and Manufacturing Execution System (MES) implementations at Life-Science organizations. Yet few industry companies have achieved this goal.

Fujirebio Diagnostics Inc. (FDI) is undergoing Digital Transformation, starting with MES / EBR implementation, resulting in a Review by Exception approach for manufacturing batch records.

Join FDI’s Samantha Schloth and Axendia’s Daniel R. Matlis for a live webinar on August 6 at 11:00 AM ET to learn how Digital Transformation is enabling Review by Exception and reducing manufacturing cycle times.
We will discuss:
* Undergoing Digital Transformation.
* Implementation strategy for success
* Moving from Paper to Digital records
* Leveraging FDA’s Risk Based Computer System Assurance Approach
* The Value of Review by Exception
* Lessons learned, challenges and opportunities

Can't make this time? Register and you will be able to watch the On-Demand recording after the event.

Aug 6, 2019 11:00 AM in Eastern Time (US and Canada)

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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.