The Cincinnati Chapter serves the Cincinnati, Dayton, Columbus, and Northern Kentucky areas as an extension of Xavier Health. We also invite our colleagues from Lexington to join us. The local chapter focuses its efforts towards organizing and providing local events involving professionals in the development, manufacture, quality control and regulatory affairs for drugs, medical devices and related products. The Cincinnati Chapter is managed by the operating team comprised of volunteers. We organize breakfast meetings throughout the year. The focus of the meetings is to provide industry professionals the ability to converse in an educational environment while enjoying presentations from the top industry professionals and FDA regulators. It offers an opportunity to network within the industry in an enjoyable and informative setting. The breakfast meetings are usually held at the Cintas Center on the Xavier University campus and include a featured presentation from a time period between 8:00 a.m. until 9:30 a.m. The Cincinnati Chapter aspires to be an integral link in education and is always looking for new volunteers whom may assist us in our efforts. Your support, comments and suggestions are the mechanism to our improved success.
Aligning Guidance Documents with FDA RegulationsCintas Center, Xavier University
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.
Your Input NeededCintas Center, Xavier University
One of your colleagues in the Xavier Health Cincinnati Chapter (Barbara Lotz from Cincinnati Sub-Zero) is in the process of trying to identify a Quality System software solution. Would you be willing to share experiences you have had with software you are using through an anonymous survey? Take our Survey!
The ROI of Regulations and QualityCintas Center, Xavier University
The Cincinnati Chapter of Xavier Health came together on January 8, 2014 to discuss the ROI of Regulations and Quality. The breakfast meeting was free of charge for Cincinnati-area pharmaceutical, medical device and regulatory professionals. All left with a better understanding of the cost for poor quality.
The speakers delivered presentations that touched on the factors that affect your ability to make quality or regulatory decisions and how you deal with them. Steve Niedelman, former Deputy Associate Commissioner of the FDA, now Lead Quality Systems and Compliance Consultant, King & Spalding, explained what companies need to understand today to avoid FDA enforcement action. The audience took good notes as Gina Brackett, FDA Cincinnati District Compliance Officer joined the discussion and shared the top three red flags that tell the FDA a company is out of control.
When asked if there is one thing she wished industry could improve, Gina indicated that she wished companies had the mindset that quality is part of everyone’s job. She further explained that the “Quality System Regulations help you make good product and are good business.”
The number one red flag that tells FDA if there are serious compliance issues with a firm is when systemic issues signal a breakdown in the culture of the company. Culture is so hard to change, that companies often have to change the management team to see a difference. All four speakers echoed this sentiment as the key ingredient to a successful business in the medical device and pharmaceutical industries.
A second red flag is related to product design. Instead of addressing problems, complaints and non-conformance, companies will come out with the next model and perpetuate the poor design. Not recognizing when to recall a product is an area of great concern.
Lastly, a third red flag that a company is in a state of serious non-compliance is when they are not assessing streams of data from all sources. In the device industry, examples would include not including service records and acceptance of non-conformance as part of the Corrective Action Preventive Action system. Is your risk assessment based on the right data? And don’t forget “you don’t know what you don’t know,” which could have serious consequences for the patients you serve.
Advice from the day: spend your time preventing issues, instead of relying on attempts to catch issues.
A newcomer to Xavier Health, Jessica Zeller, Senior Counsel at Procter & Gamble, earned high marks as she shared challenges she faced during her former role at the FDA where she was responsible for litigating pharmaceutical consent decrees.
It’s basketball season at Xavier so along with networking and learning, someone won two tickets to an upcoming Xavier basketball game. A hot commodity now that Xavier is part of the Big East Conference.