Athens, Ga. – The University of Georgia will host its first medical device regulations conference Nov. 6 at the Georgia Center for Continuing Education. Registration opens at 7:30 a.m.
The comprehensive conference on “The Medical Device Lifecycle: A Risk-Based Approach to Compliance” is co-sponsored by the UGA College of Pharmacy’s Office of BioPharma Regulatory Affairs and the U.S. Food and Drug Administration. Moderators are David Mullis, associate professor and director of the college’s graduate education program in regulatory affairs, and Penny Northcutt, president and CEO of REGSolutions LLC.
“The UGA College of Pharmacy and the FDA have worked cooperatively to provide an international workshop on pharmaceutical (current good manufacturing practices) for decades,” Mullis said. “We are very excited to offer this new educational opportunity focusing on medical devices and look forward to having attendees from medical device companies participate.”
Geared toward device manufacturers, biodesign innovators, regulatory specialists and academics, the conference will convene leaders from throughout the Southeast with industry experts in the fields of biodesign, in vitro diagnostics, medical devices, combination products and biotechnologies.
The one-day workshop will examine the medical device lifecycle from risk management to post-market surveillance and will provide educational and networking opportunities to help shape the future of medical device advancement from a regulatory science perspective, Mullis said.
Using a tutorial approach, experienced leaders from the FDA, industry and consulting firms will present on issues related to strategic implications of FDA device regulations. Topics will include risk management, usability testing, risk-based change control system implementation and post-market surveillance.
Seating is limited to 200. For more information and conference registration, see www.mdrcon.uga.edu.