Regulated companies need to be aware of trends in the industry, especially ones that create 483s or warning letters. Join us on Thursday, April 20, 2017, 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.
6:00pm Registration and Networking
8:00pm Presentation and Discussion
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
Pre-registration is $50 for PDA members and $60 for non-members
Additional $5 for Walk-in/At-Door registration.
There is a $15 discount for Government Employees and Students
PDA members: Please include your member ID number (after your name) in your registration.