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FDA Regulatory Science Lecture: Office of Device Evaluation Manufacturing Reviews
Thursday, November 14, 2013
4:00 p.m.
Room 2116 Chemical and Nuclear Engineering Bldg.
For More Information:
Professor Keith E. Herold
herold@umd.edu
Office of Device Evaluation Manufacturing Reviews
Brad Quinn
Senior Manufacturing Reviewer, Division of Cardiovascular Devices (DCD)
Lead Reviewer, Cardiac Diagnostic Devices Branch
FDA
This presentation will identify the various manufacturing submission types, how they are reviewed by DCD, and discussion of how those manufacturing changes can have a significant effect on the medical devices. Actual, de- identified examples will be used throughout the presentation.
About the Speaker
Brad Quinn has worked at the FDA for approximately 7.5 years. He is currently serving a detail as DCD’s Senior Manufacturing Reviewer responsible for facilitating the transfer of manufacturing reviewers to DCD. This detail includes developing training opportunities, serving as a focal point for questions regarding manufacturing reviews, providing an initial-level management review of DCD’s manufacturing review memos and letters, and interfacing with industry to assist in decision-making related to manufacturing submissions.
Brad’s full-time position is as a lead reviewer with the Cardiac Diagnostic Devices Branch where he performs reviews of 510(k)’s, Premarket Approval (PMA) applications, Investigational Device Exemptions (IDE’s), and Pre-submissions of devices that including patient monitors, central stations, non-invasive blood pressure monitors, external defibrillators, and other cardiac diagnostic devices.
Prior to working in ODE, Brad worked in the Office of Compliance (OC) for 6 years as a Consumer Safety Officer. During his time at OC, he performed reviews of PMAs, Establishment Inspection Reports (EIRs), recalls, consumer complaints, and regulatory/administrative actions. Additionally, Brad served two details as a Quality System Expert that included regulatory reviews and participation in policy and guidance development. Finally, he was the Network Liaison to the Cardiac Electrophysiology Matrix Network where he served as a compliance expert and represented the interests of OC in intra-Center activities.
This Event is For: Graduate • Faculty • Staff • Post-Docs
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