Event
CANCELED/CLASS STILL MEETS: FDA Regulatory Science Lecture: Design Conrols
Thursday, October 17, 2013
4:00 p.m.
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
herold@umd.edu
William McFarland's talk has been canceled, but class will still be held for students enrolled in BIOE 689R.
Overview of the 510(K) Process
William C. McFarland
Director, Division of Enforcement B
Office of Compliance
Center for Devices and Radiological Health (CDRH)
FDA
This lecture will cover the design control that should be implemented to ensure the proper path of development and to secure safety and effectiveness. In particular how the design process should be controlled to ensure that devices meet user needs, intended use and specified requirements. Additionally, design controls ensure that the design is adequately transferred into manufacturing.
About the Speaker
William C. McFarland is the Director, Division of Enforcement B, within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This divisions work relates to promoting medical device quality and acting on violative medical device regulatory practices. Mr. MacFarland has previously served in multiple other management positions in CDRH as well as held positions in the device industry and regulatory consulting industry. He has received an MBA from the University of Maryland, an MS in Biomedical Engineering from Case Western Reserve University and his BS in Electrical Engineering from Clarkson University. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence and Certified Reliability Engineer.
