Pharmaceutical and Medical Device professionals from Ohio, Indiana and Kentucky came together on October 27, 2015 for the Xavier Health Cincinnati Chapter breakfast and welcomed the new FDA Cincinnati District Director, Steven Barber.
Mr. Barber provided details about his background and 25 years at FDA – spanning 6 districts. He started his career in the laboratory doing analysis and spent many years as a Field Investigator. He comes to us from Detroit where he served as the Director of the Compliance Branch, and has now been on the job in Cincinnati for seven weeks.
Mr. Barber gave a brief presentation on FDA’s new Program Alignment Initiative that will affect investigators in FDA districts across the country. ORA will align by programs, rather than geographical zones, in an effort to enable investigators and supervisors to focus on their areas of expertise. Mr. Barber shared that he has been designated as a Director for Human and Animal Food (formerly “food and feed”), while other district directors will be designated for the remaining programs – pharmaceuticals, devices and radiological health, biologics, bioresearch monitoring (BIMO), tobacco, and imports. In the meantime, it will be business as usual as FDA continues with the implementation. Mr. Barber took questions from the audience and it generated a very good back-and-forth discussion.
Xavier graduate, Jessica Zeller was introduced to the Chapter attendees as the ORA Ombudsman nationally and will be based in Cincinnati. She spent many years at FDA in Washington, served as Counsel for Procter & Gamble, and now returns to FDA for her new role. Mrs. Zeller provided her contact information and invited members of the Chapter to reach out to her for assistance.
Chapter attendees took time at their tables to have a short discussion regarding Inspection Readiness. Once again, Mr. Barber fielded questions from the audience and discussed the importance of transparency from both FDA and Industry.
Thank you to our sponsor of this event… Allergan.
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