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Regulatory Trends and Intelligence

Thursday, April 20, 2017, 06:00am - 09:30pm

ByteGrid is proud to sponsor the Parenteral Drug Association West Coast Chapter event, Regulatory Trends and Intelligence.

Regulated companies need to be aware of trends in the industry, especially ones that create 483s or warning letters. Join us for a dive into the recent documents and a trend analysis of recent FDA enforcement data. We will cover hot topics, as well as a question and answer session for audience members, Learn from other companies’ regulatory actions to prevent the same occurrence at your own. Specific topics include warning Letters, 483 data, investigator and inspection trends, and potential impact from the new Presidential Administration. Our presenter is Oliver Yu, who has almost two decades of experience in Pharma industry analytics.

Oliver Yu is CTO and co-Founder of FDAzilla. He has 18+ years of pharma/biotech manufacturing experience at Genentech, Zymergi, and Cygnus, where he focused on large-scale data analysis, process automation, cell culture, sterility, and yield optimization.

Oliver holds a Master of Engineering in Chemical Engineering and a B.S. in Agricultural and Biological Engineering from Cornell University

6:00 PM Registration/Networking*
7:00 PM Dinner
7:45 PM Announcements
8:00 PM Presentation/Q&A
9:30 PM Closing

Location : Dominic's Restaurant, 360 Marina Boulevard, South San Francisco, CA 94080


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