Editorial Team

Editorial Staff

Publications

Editor and Director of Publications, Gloria N. Hall
Publications Manager, Lynda Goldbach
Technical Writer, Rochelle Runas
Publications Coordinator, Angie Brumley

Sales

Director of International Sales, John Phillips
North America Sales Associate, Daniel Murphy
International Markets Sales Associate, Gene Steinberg
Sales Coordinator, Angela Ferguson
European Operations Director, Elmarie Herloff-Petersen

Pharmaceutical Engineering Committee

Chair, Jeff Hargroves, ProPharma Group Inc.
Co-Chair, Judith S. Samardelis, MedImmune Inc.
Stephen Bryan, AstraZeneca
Nissan Cohen, Rohrback Cosaco Systems Inc.
Rajesh V. Dave, Bristol Myers Squibb
Charlotte Enghave Fruergaard, PhD, NNE Pharmaplan
Michelle M. Gonzalez, PE, BioPharm Engineering Consultant
Michael R. Goodman, Compliance-Insight
Carolyn A. Griffiths, Ipsen Biopharm Ltd.
Wendy T. Haines, PhD, Mangan Inc.
James B. Hills, Retired
Barbara J. Lanman, Roche Diagnostics Operations Inc.
Jennifer Lauria Clark, CPIP, Commissioning Agents, Inc.
Kate McCorriston, IPS
Catherine E. Middelberg, Pfizer
Louis L. Milano, Johnson & Johnson
James M. O'Brien, NAMA Industries Inc.
Mark A. O'Donnell, Azzur Group, LLC
Jeffery N. Odum, CPIP, IPS
Panagiotis A. Papadopoulos, Villanova University
Mary S. Poor, Commissioning Agents, Inc.
Terry J. Seanard, Jr., Tufts University
Murray A. Sterling, Precis Engineering Inc.
Pravin K. Todkar, Siemens Ltd.
Steven J. Wisniewski, Commissioning Agents, Inc.
Bin Xu, Novo Nordisk Pharmaceutical Co. Ltd.
James L. Ziegenmier, Pfizer
Joerg Zimmermann, Vetter Pharma Fertigung GmbH

Editorial Review Board

Praveen Bezawada-Joseph, Fisher BioServices
Purusottom Bhattacharjee, Fresenius kabi Oncology
Rory Budihandojo, Boehringer Ingelheim Pharma
Jose A. Caraballo, Amgen
John T. Connor, Telstar Life Sciences
Robert Del Ciello, PE, Northshire Associates
Dr. Thomas C. Dine, Dine Consultancy Ltd.
Martin Düblin, Y-Tec GmbH
Ronald C. Gaughf, Eli Lilly & Co. (retired)
Mervyn L. Hamer, Novavax
Dr. Wei Liu, Genentech Inc.
Orlando Lopez, CIBA Vision
Joseph J. Manfredi, GMP Systems, Inc.
Allan Marinelli, Quality Validation 360 Inc.
Paul A. Melamud, QPharma
Andre J. Petric, Kraemer US LLC
Philippe Robin, Jacobs France
Andrzej J. Szarmanski, Polpharma SA
Takeshi Takashima, Powrex Corp.
Richard S. Tessier, PE, Novartis Pharmaceuticals Corp.
Dr. Slawomir Wielinski, GlaxoSmithKline Pharma SA
Stephanie A. Wilkins, PE, PharmaConsult US Inc.
Bruce R. Williams, Williams Process Ltd.
Jing Zhou, M+W Shanghai Co., Ltd.

Community of Practice (COP) Editorial Reviewers

Active Pharmaceutical Ingredients (API)

Bill Jarvis, CRB Consulting Engineers, Inc.
Julian Wilkins, PharmaConsult US Inc.

Biotechnology (Biotech)

Steve Orichowskyj, Hargrove Life Sciences
Richard A. Schoenfeld, BioWorks Consulting

Commissioning and Qualification (C&Q)

Robert Adamson, RBQ Services Limited
Nuala Calnan, PhD Reseacher, Dublin Institute of Technology
Vince Cebular, IPS
Dave Dolgin, Abbott Labs
Petter Gallon, AstraZeneca AB
Michelle Whipple, Ipsen

Containment

Marc Abromovitz, Johnson & Johnson
Peter Marshall, AstraZeneca Pharmaceuticals
Ed Sargent, E V Sargent LLC
Morihiko Takeda, Pharma Solutions Co Ltd
Julian Wilkins, PharmaConsult US Inc.

Critical Utilities (CU)

Michelle Gonzalez, BioPharm Engineering Consultant
Phil Sumner, Pfizer
Norman Goldschmidt, Genesis Engineers Inc

Disposables

Adam Goldstein, Genentech
Wayne Flaherty, Compliance Concepts International, Inc.
Pietro Perrone, Millipore Corporation
John Stover, AdvantaPure/NewAge Ind.

Engineering Standards Benchmarking

Frank Smith, Merck & Co Inc
David Hogenson, Amgen
Francesca McBride, Jacobs Consultancy, PharmaBio Practice

Good Automated Manufacturing Practice (GAMP)

Winnie Cappucci, Bayer Healthcare, Retired
Chris Clark, Napp Pharmaceuticals Ltd
Waunetka Clark, Abbott Laboratories
Mark Foss, Lonza Biologics Plc
Hasse Greiner, Novo Nordisk A/S
Paul Irving, Northern Life Sciences Ltd
Colin Jones, Conformity Ltd.
Paige Kane, Pfizer Pharmaceuticals
Tony Margetts, Factorytalk Co., Ltd.
Barbara Nollau, Amgen
Randy Perez, Novartis Pharmaceuticals
Radha Ramesh, Celgene Corp
Gregory Ruklic, Systems & Compliance Professional, Independent
Guy Wingate, GlaxoSmithKline
Sion Wyn, Conformity Ltd.

Good Control Laboratory Practice (GCLP)

Kapil Bhargava, Central Drugs Control Org (CDSCO)
Raghu Raghunandanan, Consultant
Jawahir L. Sipahimalani, Chem-Med Analytical Laboratories

Heating, Ventilation, and Air Conditioning (HVAC)

Mel Crichton, Retired
Nick Haycocks, Amgen
Gary Knight, Commissioning Agents, Inc.
Don Moore, Eli Lilly & Co
Norman Goldschmidt, Genesis Engineers Inc

Investigational Products (IP)

Esther Sadler-Williams, Catalent Pharma Solutions
Bob Misher, AndersonBrecon Clinical Services
Robert Smith, Genzyme Ltd
Gerald Finken, Clinical Supplies Management Inc

Operations Management

Jim Curry, OpStat Group Inc.
Nick Davies, NDA Consultants
Jim McKiernen, McKiernan Associates
Dennis Stamm, CH2M Hill

Oral Solid Dosage (OSD)

Yuichi Watanabe, MSD KK (Merck & Co.)
Stephen Yu, Bayesian-Consulting LLC

Packaging

Lars Olsen, NNE Pharmaplan
Nancy St. Laurent, St. Laurent Consulting

Process Analytical Technology (PAT)

Kevin Klopfer, Celgene Corp
Andreas Schneider, Roche Diagnostics (Switzerland) AG

Process/Product Development (PPD)

Mark Angelino, Baxter Healthcare Corporation
James Blackwell, The Windshire Group, LLC

Project Management (PM)

Leo O. Hura, Mediate With LH LLC
Dave Koncak, Pfizer Inc

Sterile Products Processing (SPP)

Gordon Farquharson, Critical Systems Ltd
Jack Lysfjord, Lysfjord Consulting LLC

Sustainable Facilities

Nigel Lenegan, Energy & Carbon Reduction Solutions Ltd.