A Special Thank You to ISPE Guidance Document Team Members

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ISPE would like to express our considerable appreciation and sincere thanks to the individuals who have freely given their valuable time and expertise to help produce the ISPE family of Guidance Documents.

During the 15 years in which ISPE has been publishing guidance, dedicated volunteers have contributed their worldwide experience and knowledge to produce guidance which benefits the entire global pharmaceutical community. Volunteer reviewers from both industry and regulatory agencies also have provided real-world commentary on drafts, helping to enhance guidance content. Their contributions continue to be fundamental in maintaining and enhancing the relevance and quality of all ISPE Guidance Documents.

We hope that the entire ISPE membership will join us in recognizing the enormous efforts made by these volunteers so that they can receive the recognition they truly deserve for their indispensable contributions.

The ISPE Guidance Document Development Teams represent participation from numerous pharmaceutical specialties and all regions of the global pharmaceutical community. The following is the list of volunteers, from 2011 to the present.

Note: Contact information current at time of guidance document publication.

ISPE PQLI® Guide Series: Part 4 – Process Performance and Product Quality Monitoring System (PP&PQMS)

  • Winston R. Brown, Alcon Research, Ltd. – A Novartis Division, USA
  • Chunsheng Cai, PhD, Vertex Pharmaceuticals, Inc., USA
  • Joseph Famulare (Co-Lead), Genentech Inc., USA
  • Jennifer Gehle-Novak, Fresenius Kabi USA, LLC, USA
  • Jaspreet Gill, Baxter Healthcare Corp, USA
  • Rob Hughes, Rob Hughes Associates, United Kingdom
  • Claudia Q. Lin, PhD, Bayer Healthcare, USA
  • Bryan Liptzin, Amgen Inc., USA
  • Steven J. Martino, Johnson & Johnson, USA
  • George P. Millili, PhD (Co-Lead), Merck & Co., Inc., USA
  • Jason J. Orloff, PharmStat, USA
  • Christopher Potter, PhD, ISPE PQLI Technical Project Manager, United Kingdom
  • Ronald C. Stellon, AstraZeneca, USA
  • Dr. Thirunellai G. Venkateshwaran, PhD, Genentech Inc., USA

ISPE Good Practice Guide: Booklet Labels

  • Brigitte Behrends, F. Hoffmann-La Roche Ltd., Switzerland
  • David Glynn, Sunovion Pharmaceuticals Inc., USA
  • Karen Gram (Lead), Novo Nordisk A/S, Denmark
  • Kirsten Lingbeek-Brummelhuis, Genzyme Europe B.V., The Netherlands
  • Claudio Lorck, Temmler Werke GmbH, Germany
  • Pierre Lories, UCB Pharma S.A., Belgium
  • Phillippe Muller, Fisher Clinical Services GmbH, Switzerland
  • Marloes Seesing, Genzyme Europe B.V., The Netherlands
  • Sascha Sonnenberg, Marken Ltd., Germany

ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

  • Ajay Acharya, Merck & Co., Inc., USA
  • Anneli Bergqvist, AstraZeneca, Sweden
  • Ann Calnan, GlaxoSmithKline (GSK), United Kingdom
  • Miriam Cruz, Eisai, USA
  • Fran Degennaro-Culver, Merck & Co., Inc., USA
  • Kristen DeVito, Catalent Pharma Solutions, USA
  • Lisa Falzone, Bayer Healthcare Pharmaceuticals, USA
  • Beth Gardner, Takeda, USA
  • Christine Harloff, Bayer Pharma AG, Germany
  • Kay-Christian Karstadt, Multipharma GmbH, Germany
  • Peter Kulmburg, Roche, Switzerland
  • Dawn Lundin, Merck & Co., Inc., USA
  • Karen Main, Astra Zeneca, USA
  • Lee Miller (Co-Lead), Merck & Co., Inc., USA
  • Lars Muller, Novo Nordisk A/S, Denmark
  • Peter Orosz, Boehringer Ingelheim, Germany
  • Sarbari Roy, AstraZeneca, Sweden
  • Esther Sadler-Williams (Co-Lead), Catalent Pharma Solutions, United Kingdom
  • Hans von Steiger, Pfizer Inc., USA
  • Andrea Zobel, Marken Ltd., Germany

GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

  • Kevin Ashley, Siemens Healthcare Diagnostics, United Kingdom
  • Karen Ashworth (Co-Lead), Karen Ashworth Consulting, United Kingdom
  • Roger Buchanan, Lilly UK, United Kingdom
  • Jonathan Davey, Provalidus Ltd., United Kingdom
  • Stephen Dawson, Eden Biodesign Ltd., United Kingdom
  • Angille K. Heintzman, NHS Blood and Transplant, United Kingdom
  • Daniel G. Mewborn, Eli Lilly and Company, USA
  • Daniel Montgomery, Covance, Inc., USA
  • Radha Ramesh, TCS, USA
  • Genni Sanders, Systematicity, United Kingdom
  • George Smerdon, Industrial Technology Systems Ltd. (ITS), United Kingdom
  • Paul Smith, Agilent Technologies, United Kingdom
  • Kimberly Stanton, QPharma, Inc., USA
  • David Stokes, Business & Decision Life Sciences, United Kingdom
  • Thanabalan Subramanian, GE Healthcare, United Kingdom
  • Matthew Theobald, Three Circles, United Kingdom
  • Steve Tinson, Scitech, United Kingdom
  • Simon Topham, Napp Pharmaceuticals Limited, United Kingdom
  • Anders Vidstrup, NNIT A/S, Denmark
  • Linda Waddick, Eli Lilly and Company, USA
  • Charlie Wakeham (Co-Lead), Pall Life Sciences, United Kingdom

GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

  • Rachel Adler, Janssen Pharmaceutical Companies of J&J, USA
  • Peter Brandstetter, Arcondis GmbH, Austria
  • David M. Dube, AVEO Pharmaceuticals Inc., USA
  • Karen Evans, GlaxoSmithKline, USA
  • Craig R. Johnson, Amgen Inc., USA
  • Carol Lee, JRF America, USA
  • Kiet T. Luong, GlaxoSmithKline, USA
  • Bob McDowall, McDowall Consulting, United Kingdom
  • Mark Newton (Co-Lead), Eli Lilly and Company, USA
  • Judith S. Samardelis, MedImmune Inc., USA
  • Paul Smith, Agilent Technologies, United Kingdom
  • Lorrie Vuolo-Schuessler (Co-Lead), GlaxoSmithKline, USA
  • Peter Ward, IDBS, United Kingdom
  • Christopher H. White, Eisai Inc., USA

ISPE Good Practice Guide: Quality Laboratory Facilities

  • Mark A. Butler, IPS, USA
  • Mary Ellen Craft, Fluor, USA
  • Thomas J. Creaven, Schering-Plough Corp., USA
  • Cesar B. Daou, PE, Daou Engineers Inc., USA
  • Donna A. DeFreitas, Vanderweil Engineers, USA
  • James J. Dolceamore, AstraZeneca Pharmaceuticals LP, USA
  • Dr. William E. Ferguson, Ferguson Consulting LLC, USA
  • Frederick L. Fricke, PhD, FDA, USA
  • Peter B. Gardner, Torcon Inc., USA
  • Michelle M. Gonzalez, BioPharm Engineering Consultant, USA
  • Gerard J. Guillorn, M+W Shanghai Co., Ltd., USA
  • Terry A. Jacobs, AIA, Jacobs/Wyper Architects, LLP, USA
  • Kaushik S. Master, Amgen Inc., USA
  • Catherine E. Middelberg, Pfizer, USA
  • James M. O’Brien (Lead), NAMA Industries, Inc., USA
  • Euan D. Smith (Co-Lead), MSD, United Kingdom
  • Kimberly D. Snyder, Proteus, USA
  • Dr. Gregory L. Tewalt, Samsung Biologics, South Korea

ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems

  • Stefan Aebi, Novartis Pharma AG, Switzerland
  • Ben Battat, IN USA, Inc., USA
  • Anthony Bevilacqua, PhD, Mettler Toledo Thornton, Inc., USA
  • Will Brown, MECO, USA
  • Vince Ciufia, OSTI Inc., USA
  • Nissan Cohen, Rohrback Cosaco Systems, Inc., USA
  • Ken Gethard, PhD, Schering Plough Global, USA
  • Ismail Gobulukoglu, PhD, Aquafine Corporation, USA
  • Michelle M. Gonzalez, P.E., BioPharm Engineering Consultant, USA
  • David M. Gray, Mettler-Toledo Thornton, Inc., USA
  • Tony Harrison, Pharmagraph, United Kingdom
  • Richard Kettlewell, GlaxoSmithKline, United Kingdom
  • Bill LaVoice, Aquafine Corporation, USA
  • Joe Manfredi, GMP Systems, Inc., USA
  • Neil McCarthy, Pfizer Inc., Ireland
  • Robert Neri, Sanofi, France
  • Reune Runyon, Apaco AG/Innovatec, Switzerland
  • Barbara Schilling, Ozonia North America, USA
  • Cameron Sipe, Pfizer Inc., USA
  • Teri C. (T.C.) Soli, PhD, Soli Pharma Solutions, Inc., USA
  • Philip E. Sumner, P.E. (Lead), Pfizer Inc., USA
  • Hans Sundstrom, MKS Instruments, USA
  • Robert Vecchione, Christ Aqua Pharma & Biotech NA, USA
  • Peter Vishton, P.E., Technology Engineer Consultant, USA
  • Gary Zoccolante, Siemens Water Technologies Corp., USA

ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities

  • Mel Bahr, MGS Machine Corp., USA
  • David Cheesman (Co- Lead), Eli Lilly and Company, USA
  • Tom Egan, PMMI, USA
  • Makato Eguchi, Omori Machinery Co., Ltd., Japan
  • Jan Gustafsson (Co- Lead), Novo Nordisk A/S (retired), Sweden
  • Nick Haycocks, Amgen Inc., USA
  • John Holton, Teva Pharmaceuticals, USA
  • Christian Ilsoe, Denmark
  • Barbara Lanman, Roche Diagnostics Operations, USA
  • Linda McBride, Gilead Science, Inc., USA
  • Don Moore, Eli Lilly and Company, USA
  • Chuck Reed, Weiler Engineering Inc., USA
  • Brian Saxton, Sunovion Pharmaceuticals Inc., USA
  • Nancy St. Laurent (Lead), Consultant, USA
  • David Swaim, Validation Agents, USA
  • Mark von Stwolinski, CRB Consulting Engineers, Inc., USA
  • Paul Whitby, Pfizer Inc., USA
  • David Williams (Co- Lead), Calico Associates Ltd. (retired), United Kingdom

ISPE PQLI® Guide Series: Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System

  • Michael Choi, Teva Pharmaceutical, USA
  • Bernd Boedecker, Trade & Industry Inspection Agency (German Inspectorate), Germany
  • Rob Hughes (Lead), AstraZeneca, United Kingdom
  • Lilian Hamilton, AstraZeneca, Sweden
  • Claire Myles, formerly of AstraZeneca, United Kingdom
  • Susan L. Schebler, Eli Lilly, USA
  • Mike James, GlaxoSmithKline, United Kingdom
  • Takeshi Takashima, Powrex Corp. / ISPE Japan, Japan
  • Ron Taticek, Genentech, Inc., USA
  • Gregory Tewalt, Samsung BioLogics, South Korea

ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)

  • Marc Abromovitz, Johnson & Johnson, USA
  • John Farris, SafeBridge Consultants, Inc., USA
  • Hari Floura, Floura LLC, USA
  • Andreas Flueckiger, F. Hoffmann-La Roche, Switzerland
  • Peter Marshall, AstraZeneca, United Kingdom
  • Matthew Meiners, Bureau Veritas North America, Inc., USA
  • George Petroka (Co-Lead), IES Engineers, USA
  • Robert Sussman, SafeBridge Consultants, Inc., USA
  • Barbara Taylor, Genzyme Corp., USA
  • James P. Wood (Co-Lead), Eli Lilly and Company, USA

ISPE Good Practice Guide: Comparator Management

  • Eva-Maria Borchert, Sanofi-Aventis, Germany
  • Chris Butta, Pfizer, USA
  • Henryk Junker (Co-Lead), Allergan, United Kingdom
  • Sarbari Roy, Astra Zeneca, Sweden
  • Julie Swarts, Eli Lilly, USA
  • Mark Ware (Co-Lead), Idis, USA/United Kingdom

ISPE Baseline® Guide: Volume 4 – Water and Steam Systems (Second Edition)

  • Bill Alkier, formally with Paul Mueller Company, USA
  • Robert M. Augustine, Eli Lilly and Company, USA
  • Patrick H. Banes, Astro Pak Corporation, USA
  • Thomas Beck, Recipharm Stockholm AB, Sweden
  • Dr. Anthony Bevilacqua, Mettler Toledo Thornton, USA
  • Jay C. Buffi, Pfizer Inc., USA
  • Nissan Cohen, Start-up Business Development, USA
  • Andrew W. Collentro, Water Consulting Specialists, Inc., USA
  • Sunniva Collins, Swagelok Technology Services Co.
  • Sharif Disi, MECO, USA
  • Michelle M. Gonzalez, Amgen Inc. (Retired), USA
  • Timo Heino, STERIS Finn-Aqua, Finland
  • Michael E. Holland, GE Water and Process Technologies, USA
  • Bill Huitt, W.M. Huitt Company, USA
  • Ken Kimbrel, UltraClean Electropolish, Inc., USA
  • Alex J. Konopka, Engineering Consultant (Retired), USA
  • Joseph J. Manfredi, GMP Systems, Inc., USA
  • Andreas Marjoram, Bayer Healthcare AG, Germany
  • Brian McClellan, Aqua-Chem, Inc., USA
  • Peter Petrillo, Millennium Facilities Resources, Inc., USA
  • Daryl Roll, Astro Pak Corporation, USA
  • Bruno Rossi, Millipore, France
  • Cameron Sipe (Lead), Pfizer, USA
  • Rostyslaw Slabicky, Boehringer Ingelheim Pharmaceuticals Inc., USA
  • T.C. Soli, PhD, Soli Pharma Solutions, Inc., USA
  • Philip E. Sumner, Pfizer Global Engineering, USA
  • Robert Vecchione, Christ Aqua Pharma & Biotech, USA
  • Peter T. Vishton, Pfizer Global Engineering (Retired), USA
  • James “Jim” Vogel, Process Facilities Services, Inc., USA
  • Paul Whitehead, ELGA LabWater Global Operations, United Kingdom
  • Anders Widov, MSc Chem Eng, FR PHARMA, Sweden
  • Graham C. Wrigley, PhD, Pfizer Inc., USA
  • Gary Zoccolante, Siemens Industry, Inc. Water Technologies Unit, USA

ISPE Good Practice Guide: Interactive Response Technology

  • Chedia Abdelkafi, N-Side, Belgium
  • Jerry Anderson, US Data Management, USA
  • Michael Arnold, RPh (Lead), Pfizer, USA
  • Ted Bradley, Pfizer, USA
  • Adam Brand, ICON plc, USA
  • Sue Britland, Merck, USA
  • Lynn Conway, Pfizer, USA
  • Ethan Davis, PMP, Merge Healthcare, USA
  • Massimo Eli, MSD Italia Srl, Italy
  • Miguel Feliz, Merck, EPICS Professional Organization, USA
  • Gayle Flynn, GSK, USA
  • Michelle Foust, Almac, USA
  • Charles Gasman, PharmaNet/i3, USA
  • Fiona Geiger, Cenduit LLC, USA
  • Jeroen Gerritsen, Geronomo Consultancy, Netherlands
  • Karen Gram, Novo Nordisk A/S, Denmark
  • Steve Jacobs, Global Clinical Supplies Group (GCSG), USA
  • Henryk Junker, Allergan, United Kingdom
  • Madaline Keating, Parexel, USA
  • Rongvald Lamb, Fisher Clinical Services, United Kingdom
  • Patricia Larrabee, Rochester Clinical Research, Inc., USA
  • Kristen Lingbeek-Brummelhuis, Genzyme, Netherlands Discussion Group, Netherlands
  • Lauren Litzinger, Pfizer, USA
  • Katie Mazuk, Johnson & Johnson, USA
  • Donna McDermott, Merck, EPICS Professional Organization, USA,
  • Damian McEntegart, Perceptive Informatics, United Kingdom
  • Julia Meyer, Merck, Germany
  • Christine Milligan, Fisher Clinical Services, United Kingdom
  • Vijay Pal, Cenduit LLC, USA
  • Heidi Pfefferkorn, Novartis, USA
  • Nathaniel Ramuthaga, Pfizer Clinical Operations Middle East/Africa, South Africa
  • Michael Ribic, Abbott, USA
  • Alan Robinson, Aptuit, United Kingdom
  • Tom Schultz, Johnson & Johnson, USA
  • Marloes Seesing, Genzyme, Netherlands
  • Angela Shaver, USA
  • Robert Smith, Genzyme, United Kingdom
  • Sandy Soulakian, Abbott, USA
  • Justine Swinney, Merck Corp., USA
  • Louisa Tsang, Pfizer-Hong Kong, Hong Kong
  • Lekishia White, Multipharma, USA
  • Steve Yoder, Fisher Clinical Services, IP COP-ISPE, USA

ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

  • Jamie Angelastro, Colorcon, Inc., USA
  • David Barlow, Pharmeon, Ltd., United Kingdom
  • Jeffrey H. Butler, Yonkers Industries, Inc., USA
  • Nick C. Davies, NDA Consultants, USA
  • Stephen Errico, Eisai, Inc., USA
  • Keith Gibbs, Yonkers Industries, Inc., USA
  • Rich Gunderlock, MedImmune, Inc., USA
  • John Honey, Genentech, USA
  • Leo Hura, Mediate with LH, LLC, USA
  • Peter Iles-Smith, GlaxoSmithKline, United Kingdom
  • Sean Kelly, Pfizer, USA
  • Dave Koncak, Pfizer, USA
  • Keith Lamson, Eli Lilly and Company, USA
  • Paul Loxley, Novartis Pharma AG, Switzerland
  • Mick Lynam, PM Group, Ireland
  • Chris McCann, McCann Construction Consulting, LLC, USA
  • James W. McGlade, O’Brien and Gere, USA
  • Dr. Trish Melton (Lead), MIME Solutions, Ltd., United Kingdom
  • Kevin O’Donnell, Irish Medicines Board, Ireland
  • Jeff Odum, Integrated Project Services, USA
  • Alf Penfold, Pfizer, United Kingdom
  • Joe Phelan, PM Group, Ireland
  • Andrew Roberts, MIME Solutions, Ltd., United Kingdom
  • Raymond H. Scherzer, PM-SET, LLC, USA
  • Wade Shelden, Yonkers Industries, Inc., USA
  • Greg Spanel, ProPharma Group, Inc., USA
  • Matt Stefanowicz, Catalent Pharma Solutions, USA
  • Matthew Theobald, Three Circles Consulting, Ltd., United Kingdom
  • Ian Thorne, Genzyme, United Kingdom

ISPE PQLI® Guide Series: Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example

  • Bruce Davis (Lead), Global Consulting, United Kingdom
  • Eric Ahuja, Merck, USA
  • Brett Alexander, AstraZeneca, USA
  • Mette Bryder, Lundbeck, Denmark
  • Sue Busse, Lilly, USA,
  • Graham Cook, Pfizer, USA
  • John Donaubauer, Abbott, USA
  • John Groskoph, Pfizer, USA
  • Sandy Hopkins, AstraZeneca, USA
  • Theodora Kourti, GSK, United Kingdom
  • Mette Kraemer-Hansen, NovoNordisk, Denmark
  • John Lepore, Merck, USA
  • Line Lundsberg-Nielsen, NNE Pharmaplan, United Kingdom
  • Roger Nosal, Pfizer, USA
  • Chris Potter, Consultant and PQLI Technical Project Manager, United Kingdom
  • Paul Stott, AstraZeneca, United Kingdom
  • Stephen Tyler, Abbott Laboratories, USA
  • Tim Watson, Pfizer, USA

ISPE PQLI® Guide Series: Part 1 – Product Realization using Quality by Design (QbD): Concepts and Principles, including Overview, Criticality, Design Space, and Control Strategy

  • Eric Ahuja, Merck, USA
  • Joanne Barrick, Eli Lilly & Company, USA
  • John Berridge, Consultant and PQLI Project Manager, United Kingdom
  • Chris Brook, GlaxoSmithKline, USA
  • Mette Bryder, H. Lundbeck A/S, Denmark
  • Sue Busse, Eli Lilly & Company, USA
  • Graham Cook, Pfizer, United Kingdom
  • Bruce Davis, Global Consulting, United Kingdom
  • Ranjit Deshmukh, MedImmune, USA
  • John Donaubauer, Abbott Laboratories, USA
  • Tom Garcia, Pfizer, USA
  • Jeff Givand, Merck, USA
  • John Groskoph, Pfizer, USA
  • Theodora Kourti, GlaxoSmithKline, United Kingdom
  • Mette Kraemer-Hansen, Novo Nordisk, Denmark
  • Jay Lakshman, Novartis, USA
  • Steve Laurenz, Abbot Laboratories, USA
  • John Lepore (Co-Lead), Merck, USA,
  • Line Lundsberg-Nielsen (Co-Lead), NNE Pharmaplan, United Kingdom
  • Vincent McCurdy, Pfizer, USA
  • Gordon Muirhead, GlaxoSmithKline, United Kingdom
  • Roger Nosal (Co-Lead), Pfizer, USA
  • Gary O’Connor, Pfizer, United Kingdom
  • Wim Oostra, MSD, Netherlands
  • Chris Potter, Consultant and PQLI Technical Project Manager, United Kingdom
  • Tom Schultz, Johnson & Johnson, USA
  • Kevin Siebert, Eli Lilly & Company, USA
  • Shailesh Singh, Sandoz, USA
  • Chris Sinko (Co-Lead), Bristol-Myers Squibb, USA
  • William Spanogle, Johnson & Johnson, USA
  • Jim Spavins, Pfizer, USA
  • Paul Stott, AstraZeneca, United Kingdom
  • Mani Sundararajan, AstraZeneca, USA
  • Stephen Tyler, Abbott Laboratories, USA
  • Hedinn Valthorsson, Novartis, Switzerland
  • Kim Vukovinsky, Pfizer, USA
  • Tim Watson, Pfizer, USA

ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

  • Nicholas Andreopoulos, Pfizer, USA
  • Joerg Block (Co-Lead), Bayer HealthCare AG, Germany
  • Nuala F. Calnan, Dublin Institute of Technology, Ireland
  • Vincent J. Cebular, IPS, USA
  • Robert E. Chew, PE, Commissioning Agents, Inc., USA
  • Peter Werner Christensen, CPIP, NNE Pharmaplan A/S, Denmark
  • Kimberly A. Dahmen, Abbott Laboratories, USA
  • David D. Dolgin (Co-Lead), Abbott Laboratories, USA
  • Rose Mary A. Dollard, Johnson & Johnson, USA
  • Daniel G. Franklin, CIRM, CxA, IPS, USA
  • Matthew Scott Hamm, Eli Lilly & Co., USA
  • Timothy P. Howard, CPIP, PE, Commissioning Agents, Inc., USA
  • Angela McCarthy, GlaxoSmithKline, Ireland
  • Matthew R. McMenamin, GlaxoSmithKline, USA
  • Armen J. Nahabedian, Pfizer, USA
  • Ryan W. Stewart, GlaxoSmithKline, USA
  • Guy A. S. Wingate, GlaxoSmithKline, United Kingdom
  • Steven J. Wisniewski, Commissioning Agents, Inc., USA

ISPE Baseline® Guide: Volume 3 – Sterile Product Manufacturing Facilities

  • Jeff Biskup, CRB Consulting Engineers, Inc., USA
  • Mel Crichton, Eli Lilly & Company (retired), USA
  • Bruce Davis (Lead), Bruce Davis Global Consulting, United Kingdom
  • Gordon Farquharson, Critical Systems Ltd., United Kingdom
  • Russell Madsen, The Williamsburg Group, LLC, USA
  • Mark Von Stwolinski, CRB Consulting Engineers, Inc., USA

ISPE Good Practice Guide: Process Gases

  • Katrin Åkerlindh, Linde Gas, Sweden
  • Tracey Coffey, Commissioning Agents, Inc., USA
  • Joseph DePaul, Skye Technical Services, USA
  • Roger Emmett, Praxair Distribution Inc., Canada
  • Michelle Gonzales, Amgen (retired), USA
  • Nicholas Haycocks (Co-Lead), Amgen, USA
  • Wade Johnston, Ciba Vision Corp., USA
  • Tom Larkin, Integrated Process Technologies, USA
  • Chad Larrabee (Co-Lead), Ingersoll Rand Industrial Technologies, USA
  • Jerold Martin, Pall Corp., Life Sciences div., USA
  • Bonnie Smelser, Progenics Pharmaceuticals Inc., USA
  • Frank van der Steen, SynCo Bio Partners B.V., The Netherlands
  • Peter Vishton, P.E., IPS Contract Engineer, GMP Utility Systems, USA
  • Ian Nicholson, IDT Australia, Australia

ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment (FSE)

  • Bob Adamson (Co-Lead), RBQ Services Ltd., United Kingdom
  • Joerg Block, Bayer HealthCare AG, Germany
  • Nuala Calnan, PM Group, Ireland
  • Bob Chew, Commissioning Agents, Inc., USA
  • Petter Gallon, AstraZeneca AB, Sweden
  • David Petko, Auxilium Pharmaceuticals, Inc., USA
  • Guy Wingate (Co-Lead), GlaxoSmithKline, United Kingdom
  • Steve Wisniewski (Co-Lead), Commissioning Agents, Inc., USA

ISPE Good Practice Guide: Cold Chain Management

  • Luca Arrighi, Foster Wheeler Italiana Srl, Italy
  • Dr. Jean-Pierre Emond, University of South Florida Polytechnic, USA
  • Geoffrey Glauser, Health & Human Services – BARDA, USA
  • Paul Harber, Lilly, USA
  • Nicholas Haycocks (Lead), Amgen, USA
  • Brian Lee, Schering-Plough, USA
  • Elizabeth Martinez, Terra Farma S.A De C.V., Mexico
  • Matthew McMenamin, GlaxoSmithKline, USA
  • Neritan Mustafa, Biogen Idec, USA
  • John Oliver, Clarion Construction, Inc., USA
  • Karen Oliver, World Courier Inc., USA
  • Douwe Rijpkema, Quality in Maintenance BV, Netherlands
  • Brian Saxton, Sunovion Pharmaceuticals Inc., USA
  • Ted N. Schnipper, P.E., SLAC National Accelerator Laboratory, USA
  • Jeff Seeley, Merck & Co., Inc., USA
  • Walt Spendley, Intervet/Schering-Plough, USA
  • Carol Susla, Cangene Corporation, Canada
  • Brian Venturi, Merck & Co., Inc., USA
  • Jean Vezina, , USA
  • Brian Wallin, Amgen, USA
  • Guy Wingate, GlaxoSmithKline, United Kingdom
  • Graham Wrigley, Pfizer, USA

GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)

  • Karen Ashworth, Karen Ashworth Consulting Ltd., United Kingdom
  • Roger Buchanan, Eli Lilly & Co. Ltd., United Kingdom
  • Mark Cherry (Lead), AstraZeneca, United Kingdom
  • Reetu Chopra, Teva Pharmaceuticals, United Kingdom
  • Peter Falcon, AstraZeneca, United Kingdom
  • David James, Invensys System (UK) Ltd., United Kingdom
  • Peter Iles-Smith, GlaxoSmithKline, United Kingdom
  • Martin Isherwood, Eli Lilly & Co. Ltd., United Kingdom
  • Malcolm Knott, Industrial Technology Systems Ltd., United Kingdom
  • Walfraid Laibacher, Honeywell Building Solutions GmbH, Germany
  • Hilary Mills-Baker (Co-Lead), WSP CEL Ltd., United Kingdom
  • Brian Nolan, Organon Ireland Ltd., Ireland
  • Blaise Polentes, Sanofi-Aventis R&D, USA
  • Bo Reedtz, Denmark
  • George Smerdon, Industrial Technology Systems Ltd., United Kingdom
  • Sue Tuxford, Emerson Process Management, United Kingdom
  • Rainer Van Deursen, Eurotherm Deutschland GmbH, Germany
  • Gerhard Werling, Rockwell Automation Solutions GmbH, Germany
  • Guy Wingate, GlaxoSmithKline, United Kingdom
Last Update: 12 July 2013

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