 Kurt Brorson, PhD
Biologist
CDER
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Life Sciences Building 64
Room 1036
Silver Spring, MD 20993
(301) 796-2193
Kurt.brorson@fda.hhs.gov |
 Ursula Busse, PhD
Head Project Office
Global Pharmaceutical Operations
Novartis Pharma AG
WSJ-Forum 3.1.100.49
Fabrikstrasse 35
Basel CH-4002
Switzerland
41-61-324-0214
Ursula.busse@novartis.com |
|
 Michele Creech
Quality Operations Manager
Talecris Biotherapeutics
8368 US 70 West
QO-PQM Zone 1
Clayton, NC 27520
(919) 359-4162
Michele.creech@talecris.com
|
 Bob Dana
Senior Vice President
Quality & Regulatory Affairs
PDA TRI
Parenteral Drug Association
4350 East West Highway, Suite 150
Bethesda, MD 20814
(301) 656-5900 ext. 224
dana@pda.org
|
|
 Ian Elvins
Vice President, Quality
Lonza Biologics
101 International Drive
Portsmouth, NH 03801
(603) 610-5358
Ian.elvins@lonza.com
|
 Jose Goin, PhD
Associate Director, Quality Control Network Operations
Genentech, Inc.
1000 New Horizons Way
MS 1108
Vacaville, CA 95688
(707) 454-5275
JGoin@gene.com
|
|
 Jeffrey Hartman
Validation Manager
Merck and Company
PO Box 4
Stop WP97-B120
West Point, PA 19486
(215) 652-8101
Jeffrey_hartman@merck.com
|
 Rickey Lu
Associate Director, Director
Manufacturing Science & Technology
MedImmune
23108 Turtle Rock Terrace
Clarksburg, MD 20871
(925) 408-4723
lur@medimmune.com
|
|
 Miguel Montalvo
President
Expert Validation Consulting, Inc.
261 Beason Pointe Drive
Ocoee, FL 34761
(407) 587-6540
mmontalvo@expertvalcon.com
|
 Wanda Neal
Senior Vice President
Programs and Registration Services
Parenteral Drug Association
4350 East West Highway, Suite 150
Bethesda, MD 20814
(301) 656-5900 ext. 111
neal@pda.org
|
|
 Miguel Nogueras
Global Manager of QA – Microbiology
Abbott Medical Optics (AMO)
1700 E St. Andrews Place
Mail Station: SA-2M
Santa Ana, CA 92705
(714) 247-8580
Miguel.nogueras@amo.abbott.com
|
 Mike Sadowski
Director, Sterile Manufacture Support
Baxter Healthcare
25212 W. II Route 120
Round Lake, IL 60073
(847) 270-4590
Sadowsm@baxter.com
|
|
 Andrea Viera
Senior Coordinator
Programs and Registration Services
4350 East West Highway, Suite 150
Bethesda, MD 20814
(301) 656-5900 ext. 220
Viera@pda.org
|
 Brent Watkins
Southeast Regional Sales Manager
Veltek Associates, Inc.
1039 West Bridge Street
Phoenixville, PA 19460
(252) 266-2159
bwatkins@sterile.com
|
Co-Chair – Hal Baseman
Co-Chair – Maik Jornitz