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FDA Shares a New Approach to CSV - A "Straight from the Source" Webinar


Mar 7, 2019 12:44 PM

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Francisco (Cisco) Vicenty
Program Manager, Case for Quality @U.S. Food and Drug Administration
Cisco Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the pilot structure of the Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA. The Case for Quality is a strategic priority to improve access and outcomes for patients and improve device quality by engaging industry, payers, providers, and patients to focus on the quality and performance of medical devices. Cisco began his career at FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at CDRH. Prior to his current role, Cisco was the Branch Chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, within the Office of Compliance. Cisco Vicenty developed his quality experience in the semiconductor industry as a Quality and Reliability Engineer with the Micro-Electronics Business Unit at IBM.
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.