Editorial Team

Editorial Staff

Publications

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

Sales

Director of International Sales, John Phillips 
Sales Associate, North America, Alisa Pachella
Sales Coordinator, Diane Munda
Sales Coordinator, Robin Lane

ISPE Pharmaceutical Engineering Committee

Chair, Roger Nosal, Pfizer Inc.
Jane Brown, GlaxoSmithKline (Retired)
Stephen Bryan, AstraZeneca
Nissan Cohen, Rohrback Cosaco Systems Inc.
Rajesh V. Dave, Bristol Myers Squibb
Michelle M. Gonzalez, PE, BioPharm Engineering Consultant
Michael R. Goodman, Compliance-Insight 
Wendy T. Haines, PhD, Mangan Inc.
Jeff Hargroves, Propharma Group
Jennifer Lauria Clark, CPIP,  Commissioning Agents, Inc.
Kate McCorriston, IPS
Catherine E. Middelberg, Pfizer
Louis L. Milano, Project Planning & Development LLC
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, Clinipace Worldwide
Tony Rao, Stantec Consulting Services, Inc.
Judy Samardelis, MedImmune
Terry J. Seanard, Jr.,CPIP, New England Controls, Inc.
Pravin K. Todkar, Siemens Ltd.
Steven J. Wisniewski, Commissioning Agents, Inc.
Vijay Yadav, InVentiv Health
James L. Ziegenmier, Independent Contractor
Joerg Zimmermann, Vetter Pharma Fertigung GmbH

Editorial Reviewers Board

Nuha Al-Hafez, Teva
Praveen Bezawada-Joseph, Fisher BioServices
Purusottom Bhattacharjee, Fresenius kabi Oncology
Rory Budihandojo, Boehringer Ingelheim Pharma
Jose A. Caraballo, Bayer
John T. Connor, Sales and Marketing Consultation
Steven C. Davy, NNE Pharmaplan
Robert Del Ciello, PE, Northshire Associates
Dr. Thomas C. Dine, Dine Consultancy Ltd.
Ronald C. Gaughf, Eli Lilly & Co. (retired)
Mervyn L. Hamer, Novavax
Vijay Kasireddy, CPIP, Alexion Pharmaceuticals Inc.
Willem Kools, EMD Millipore
Dr. Wei Liu, Genentech Inc.
Orlando Lopez, Allergan Inc.
Joseph J. Manfredi, GMP Systems, Inc.
Allan Marinelli, Quality Validation 360 Inc.
Paul A. Melamud, QPharma
Dr. Jakub Mocny, CPIP, Superior Controls
Andre J. Petric, Kraemer US LLC
David Stokes, Venostic Solutions Group
Andrzej J. Szarmanski, GMDP Services
Richard S. Tessier, PE, Novartis Pharmaceuticals Corp.
Stephanie A. Wilkins, PE, PharmaConsult US Inc.
Bruce R. Williams, Williams Process Ltd.

Community of Practice (COP) Editorial Reviewers

Active Pharmaceutical Ingredients (API)

  • Bill Jarvis, CRB Consulting Engineers, Inc.
  • Zuwei Jin, GE Healthcare
  • Masih Sabet, Biovail Corp

Biotechnology (Biotech)

  • Jeff Odum, CPIP, IPS
  • Steve Orichowskyj, Hargrove Life Sciences
  • Richard A. Schoenfeld, BioWorks Consulting

Commissioning and Qualification (C&Q)

  • Dave Dolgin, Abbvie
  • Eric Felz, Genzyme
  • Peter Werner Christensen, Novo Nordisk A/S
  • Michelle Whipple, Baxter

Containment

  • Peter Marshall, AstraZeneca Pharmaceuticals
  • Bob Sussman, SafeBridge Consultants, 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.
  • Yuk Chun Chiu, SeraCare Life Science
  • Ekta Mahajan, Genentech, Inc.

Engineering Standards Benchmarking

  • Jeff Fluharty, Eli Lilly & Co
  • Francesca McBride, Jacobs Consultancy, PharmaBio Practice

Good Automated Manufacturing Practice (GAMP)

  • Rory Budihandojo, Boehringer-Ingelheim
  • Chris Clark, Napp Pharmaceuticals Ltd
  • Tony Margetts, Factorytalk Co., Ltd.
  • Gregory Ruklic, Systems & Compliance Professional, Independent
  • 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.
  • Enric JoCardoso, Reig Jofre Group
  • Jim McKiernen, McKiernan Associates

Oral Solid Dosage (OSD)

  • Terry Jacobs, Jacobs/Wyper Architects, LLP
  • Paul Egee, IMA North America
  • Vijay Kshirsagar, Trac Consulting
  • Yuichi Watanabe, MSD KK (Merck & Co.)
  • Dave DiProspero, CRB
  • Michael DeBellis, Jacobs Engineering Group, Inc.
  • Steve Sirabian, Glatt Air Techniques Inc

Packaging

  • Mel Bahr, MGS Machine Corporation
  • Jim Robinson, Lachman Consultants

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)

  • Dave Koncak, Zoetis -Subsidiary of Pfizer Inc

Sterile Products Processing (SPP)

  • Thomas Spearman, Eli Lilly & Co

Sustainable Facilities

  • Nigel Lenegan, Energy & Carbon Reduction Solutions Ltd.