The Cincinnati Chapter of Xavier Health will be hosting a free breakfast meeting to discuss aligning guidance documents with FDA Cincinnati District Regulations. Find out how to ensure the practices at your facility are aligned with FDA regulations, FDA guidance documents, corporate policy, and your procedures.
Register here: http://a6164.actonsoftware.com/acton/form/6164/0020:d-0004/0/index.htm
Paul Teitell, Director, Cincinnati District, FDA will welcome the group and share his thoughts on the intent and enforcement of FDA guidance documents
Dominick Villani, Associate Director, Quality Assurance Compliance, AstraZeneca shares his experience of managing the quality integration of Amylin Pharmaceutical into Bristol-Myers Squibb in 2013 and now into AstraZeneca in 2014. Hear about Mr. Villani’s responsibility for ensuring that the regulatory requirements and guidance’s across multiple markets (i.e. FDA, EMA, PMDA, etc.) have been integrated into the implemented GMP production processes, laboratory managements systems, and Quality Management systems.
Marla Phillips, Director, Xavier Health will lead an engaging networking session as well. There will also be a door prize drawing for 2 free tickets for a Xavier men’s basketball game.
The meeting will take place on Friday, October 17, 2015 at the Schiff Conference Center, Cintas Center. It will begin at 8:00am and most likely end at 9:30am.
Thank you to our sponsor of this event… Aptalis Pharmaceutical Technologies.