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  6. Roster of the Device Good Manufacturing Practice (GMP) Advisory Committee
  1. Device Good Manufacturing Practice Advisory Committee

Roster of the Device Good Manufacturing Practice (GMP) Advisory Committee

Purpose: Reviews proposed regulations for good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations on the feasibility and reasonableness of the proposed regulations.

Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

Current Number of Vacancies: 1

Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

Chairperson
Yadin B. David, Ed.D., P.E., C.C.E. (PR)
Expertise: Biomedical Engineering
Term: 01/11/2022 – 05/31/2025
Principal
Biomedical Engineering Consultants, LLC
1111 Herman Drive, Suite 12B
Houston, TX 77004

Designated Federal Officer
Jarrod Collier, M.S.
Center for Devices and Radiological Health
Office of Management
10903 New Hampshire Avenue
WO Bldg. 66 Rm 5214
Silver Spring, Maryland 20993
Office: (240) 672-5763
Fax: (301) 847-8505

Scott Sardeson, RAC-EU/US (IR)
Expertise: Quality Systems and Regulatory Affairs
Term: 07/30/2020 – 05/31/2024
Director, International Regulatory Affairs and Quality Compliance 
3M Health Care Business
3M Center, Bldg. 275-5W-06
St. Paul, MN 55144

Robert Z. Phillips, M.B.A. (IR)
Expertise: Medical Devices - Quality Systems
Term: 12/01/2021 – 05/31/2025
Vice President, Quality and Technology, North America
Siemens Healthineers
40 Liberty Blvd. 
Malvern, PA 19355

Jeri L. Culbertson, D.N.P., B.S.N., R.N. (HP)
Expertise: Infection Prevention and Control
Term: 12/08/2021 – 05/31/2025
Infection Prevention Consultant
2377 Black Saddle Rd.
Rapid City, SD 57703

Gordon S. Gillerman, BSEET (GR)
Expertise: Standards; Quality Systems
Term: 12/08/2021 – 05/31/2024
Director, Standards Coordination Office
National Institute of Standards and Technology
100 Bureau Drive
Mail Stop 2150
Gaithersburg, MD 20899

Chiaoyun (Benson) Kuo, Ph.D.  (PR)
Expertise: Device Development
Term: 01/11/2022 – 05/31/2026
Director, Regulatory Consulting Center
Assistant Professor, Department of Regulatory and Quality Sciences
School of Pharmacy
University of Southern California
1540 Alcazar Street, CHP140
Los Angeles, CA 90033

Lisa C. Dimmick , M.S. (GR)
Expertise: Radionuclide Radiotherapy Devices
Term: 01/11/2022 – 05/31/2026
Team Leader
Medical Radiation Safety Team
U.S. Nuclear Regulatory Commission
11545 Rockville Pike
Two White Flint North, Rm# T8-F18
Rockville, MD 20852

Elise M. Owen, M.B.A. (GR)
Expertise: Standardization
Term: 01/11/2022 – 05/31/2024
Standards Executive
Environmental Protection Specialist
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue NW
Washington, DC 20004

 

GR - Government Representative
HP - Health Professional Representative
PR - Public Representative
IR - Industry Representative

 

 
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