The Medical Device Validation Handbook
ix
Author Acknowledgments
RAPS and editor, Robert Falcone, PhD, FRAPS, FTOPRA, thank the following subject matter experts for
sharing their experience and knowledge and volunteering their time to contribute to this third edition of
Medical Device Validation Handbook.
Editor
Robert Falcone, PhD, FRAPS,
FTOPRA
Regulatory Manager
Integrated DNA Technologies
IDT
Authors
Wes Bloemker, MBA
Retired
Anthony Carra, MAS, CMQ/
OE, PMP
Owner/Principal Consultant
Business Improvement Group
Jay Crowley, MS
Vice President, Medical
Devices and UDI Practice
Lead
USDM Life Sciences
David W. DiVaccaro, MS
Principal
DiVaccaro Consulting Group,
LLC
Courtney Divine
Senior Packaging Engineer
Network Partners Group
Brian K Farison
Technical Fellow
Network Partners Group
Brett D. Hofman
Senior Packaging Engineer
Network Partners Group
Beth Kroeger-Fahnestock
Director, Biopharma Production
Chemicals, New Product
Introductions
Avantor Sciences
John E. Lincoln
Owner, Principal Consultant
J. E. Lincoln and Associates
LLC
Gerry A. O’Dell, MS, AAMI
Fellow
Owner/President
Gerry O’Dell Consulting
Rod Patch, MBA
Senior Director, Package
Engineering, Product
Labeling &Digital Product
Information
Johnson &Johnson Vision
James N Polarine Jr., MA
Senior Technical Service
Manager
STERIS Corporation
Steven G Richter, PhD, MS,
RAC-US
Senior Regulatory
Microbiologist
Richco Laboratories LLC
Lisa A. Schaller, MS
Director, Quality Assurance
Varian Medical Systems, a
Siemens Healthineers
company
David W. Steinmeier, MBA
Owner
microJoining Solutions
Heather A. Valley, MS,
RAC-Global
Director Regulatory Affairs
Network Partners Group
Steven L Walfish, MBA, MS
Director, Global Technical
Operations Statistics
AstraZeneca
Timothy Wech, MSE, PE
VP, IT and PMO
Network Partners Group