Advisory Committees

Roster of the Devices 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: 2

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.(PR)

Expertise: Biomedical Engineering
Term: 12/10/2014 to 05/31/2018
Biomedical Engineering Consultants, LLC
1111 Hermann Drive, Suite 12B
Houston, TX 77004

Designated Federal Official
James Swink
Center for Devices and Radiological Health
Office of Device Evaluation
Food and Drug Administration
10903 New Hampshire Ave.
WO 66 Room# 1609
Silver Spring, MD 20993
Office: 301-796-6313
Fax: 301-847-8122

Hans Beinke, NMN (IR)
Expertise: Quality Management Systems
Term: 11/29/2013 - 05/31/2017
Vice President
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355

Courtney J. Schoessow, M.P.H. (PR)
Expertise: Public Health
Term: 07/30/2013 – 05/31/2017
President & CEO
Public Health Works Consulting, LLC
W2880 Granton Road
Granton, WI 54436

Laurence R. Upjohn, Pharm D. (GR)
Expertise: Applied Mathematics; Pharmacology
Term: 07/30/2013 – 05/31/2017
Research Scientist Supervisor
Chief, Science and Education Section
CA Dept. of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
P.O. Box 997413
Sacramento, CA 95899

David C. Cranmer, Ph.D.(GR)
Expertise: Materials Science and Engineering
Term: 09/11/2015 – 05/31/2019
Senior Researcher
National Institute of Standards and Technology
100 Bureau Drive
Bldg. 301 Room B173-7
Gaithersburg, MD 20899

 

Thomas E. Herrera, M.D. (GR)
Expertise: Qualified Sealed Source and Device Reviewer
Term: 07/30/2013 – 05/31/2017
Senior Project Manager
U.S. Nuclear Regulatory Commission
11545 Rockville Pike
Bldg. Two White Flint Mail Stop: T8E24
Rockville, MD 20852

Michelle Lott, RAC (IR)
Expertise: Regulatory & Quality Strategy
Term: 04/26/2016 – 05/31/2019
Principal and Founder
Lean RAQA Systems, LLC
12602 N Summer Wind Drive
Marana, AZ 85658

 

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

 

Page Last Updated: 07/05/2016
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