Eighty members of the Cincinnati Chapter of Xavier Health came together on October 17, 2014 to discuss aligning guidance documents with FDA Cincinnati District Regulations. The breakfast meeting was free of charge for Cincinnati-area pharmaceutical, medical device and regulatory professionals. All left with a better understanding of ensuring practices at their facility are aligned with FDA regulations, FDA guidance documents, corporate policy, and procedures.
Paul Teitell, Director, Cincinnati District, FDA welcomed the group and shared his thoughts on the intent and enforcement of FDA guidance documents
Dominick Villani, Associate Director, Quality Assurance Compliance, AstraZeneca shared his experience of managing the quality integration of Amylin Pharmaceutical into Bristol-Myers Squibb in 2013 and now into AstraZeneca in 2014. Mr. Villani’s discussed his 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 led an engaging Q&A session as well. A door prize drawing for 2 free tickets for a Xavier men’s basketball game was presented to one of the attendees.
Thank you to our sponsor of this event… Aptalis Pharmaceutical Technologies.