 Ursula Busse, PhD
Head Project Office
Global Pharmaceutical Operations
Novartis Pharma AG
Ursula.busse@novartis.com |
 Michele Creech
Quality Operations Manager
Grifols, Inc.
Michele.creech@grifols.com |
|
 Bob Dana
Senior Vice President
Quality & Regulatory Affairs
PDA TRI
dana@pda.org
|
 Ian Elvins
Vice President, Quality
Lonza Biologics
Ian.elvins@lonza.com
|
|
 Jose Goin, PhD
Associate Director, Quality Control Network Operations
Genentech, Inc.
JGoin@gene.com
|
 Jeffrey Hartman
Validation Quality Assurance
Merck and Company, Inc.
Jeffrey_hartman@merck.com
|
|
 Rickey Lu
Associate Director, Director
Manufacturing Science & Technology
MedImmune
lur@medimmune.com
|
 Miguel Montalvo
President
Expert Validation Consulting, Inc.
mmontalvo@expertvalcon.com
|
|
 Wanda Neal
Senior Vice President
Programs and Registration Services
Parenteral Drug Association
neal@pda.org
|
 Miguel Nogueras
Global Manager of QA – Microbiology
Abbott Medical Optics (AMO)
Miguel.nogueras@amo.abbott.com
|
|
 Mike Sadowski
Director, Sterile Manufacture Support
Baxter Healthcare
Sadowsm@baxter.com
|
 Emily Shacter, PhD
ThinkFDA, LLC
emily.shacter@ThinkFDA.com
|
|
 Stephanie Ko
Manager, Lecture Education
Parenteral Drug Association
ko@pda.org
|
 Brent Watkins
Southeast Regional Sales Manager
Veltek Associates, Inc.
bwatkins@sterile.com
|
Co-Chair – Hal Baseman
Co-Chair – Maik Jornitz