Program Planning Committee

Co-Chair – Hal Baseman
Chief Operating Officer
ValSource, LLP
hbaseman@valsource.com
Co-Chair – Maik Jornitz
Chief Operating Officer
G-Con
Maik.jornitz@sartorius-stedim.com
   

Program Planning Committee

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