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FDA Shares Quality Considerations for Continuous Manufacturing - A "Straight from the Source" Webinar

01:29:00

Apr 17, 2019 10:31 AM Eastern Time (US and Canada)

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Speakers

Thomas O’Connor, Ph.D
Senior Chemical Engineer @OTR, Office of Pharmaceutical Quality, CDER, FDA
Dr. O’Connor is a senior chemical engineer in the Division of Product Quality Research in the Office of Testing and Research and is a member of CDER’s Emerging Technology Team. He is a member of the continuous manufacturing guidance working group and one of the government liaisons to the US Pharmacopeia expert committee on continuous manufacturing. Prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he held job functions in both process analytical technology and process control. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.
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.