FDA Office Hours and Next Meeting
November 8, 2018 at Cintas Center, Xavier University
BREAKFAST, 8:00am - 8:30am
Share breakfast and conversation with FDA and local members of our industries. Network and converse on common problems and how others are solving those issues.
Chapter Meeting, 8:30am - 10:30am
The meeting will include interactive discussion on four critical topics to our industries today:
Pharma Cultural and Metrics Initiatives: Learn how FDA is using the Xavier Cultural Model on inspection and how you can prepare your organization.
Good Supply Practices (GSPs): Developed by Xavier, FDA and industry, GSPs are currently being adopted as an International Standard by BSI and included as a General Chapter by USP. Gain practical techniques to attack the true root cause of your supply chain failures and protect your organization and the patients you serve.
Chief Quality Officer (CQO) Forum: Learn about the work being done with a cross section of CQO’s across industries to create the Quality Organization of the 21st Century to Protect and Promote Patient Health. Understand the paths being considered, how you might begin to apply these concepts and provide input into this effort.
AI in Manufacturing: Learn how your peers are using AI in manufacturing today so you can advance your company’s operations.
Join FDA and your local industry colleagues in thought-provoking discussions that will leave you armed with practical ways to make a difference in your organization. Become a member of the Cincinnati Regional Chapter.
FDA OFFICE HOURS, 10:30 am-12:30 pm
Jessica L. Zeller, Office of Regulatory Affairs (ORA) Ombudsman at FDA, and Joseph R. Strelnik, Medical Device Specialist, FDA-ORA, invite Chapter members to reserve a one-on-one time to talk with them so they can focus on you, your company, and your questions. This is for Chapter members only. Please click here to become a member, or if you are already a member, reserve your spot now:
How can an Ombudsman help you? An Ombudsman is a neutral, impartial person who investigates and settles disputes and resolves complaints. The Office of Regulatory Affairs (ORA) Ombudsman’s Office serves as a one-stop-shop for informal advice or consultation for external stakeholders who have complaints or inquires.
Engage with member companies such as:
Timely Content: Each meeting will involve timely content on the forefront of FDA strategic priorities and challenges you are facing each day.
Engaging Discussions: Join your colleagues in discussing purpose-driven content, successful practices for how to address the challenges you face, and ways to influence the direction of the industry.
Powerful Solutions: Walk out of each meeting armed with solutions, ideas, best practices and an even greater awareness of the total ecosystem that impacts your organization.
Meaningful Connections: Take advantage of the wealth of opportunity to meet local FDA and industry colleagues. Participate in the bi-annual chapter meetings and use your voucher towards one Xavier Health conference or summit.
Resources and Past Events
Chapter Meeting June 5, 2018. Included a thought provoking presentation and discussion around "Why Quality Does't Matter." To see the meeting presentation, click here.
Chapter Meeting February 1, 2018 included:
A live web conference, Half Day with FDA - The Future: Alignment and Reliance, free for Chapter members. We led a half-day virtual web conference with FDA officials to gain insight on the highest priorities they have within their organizations.
Chapter members had a chance to ask questions of each FDA official as we connected with them through the live web conference.
After the web conference, we facilitated table discussions on what was heard. We provided feedback to the FDA on any thoughts members had to collaboratively address the challenges they want to tackle with industry.
Chapter Meeting October 11, 2017. To see the kick-off meeting's presentation, click here.