Guidance Document Teams

A Special Thank You to Guidance Document Team Members

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 20 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: Company affiliations current at time of guidance document publication.

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  • Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

    • Birger Bockius, Merck Electronics KGaA, Germany
    • Malcolm Cunningham, Chargepoint Technology, United Kingdom
    • Dr. Andreas Flückiger, Andreas Flückiger Consulting, Switzerland
    • Oliver Gottlieb, NNE & PharmaCon Service, Denmark
    • Dr. Michele Grassi, Techniconsult Group SB, Italy
    • Daisuke Hirasawa, Chugai Pharma Manufacturing Co. Ltd., Japan
    • Peter Marshall, CEng, MIChemE, AstraZeneca (retired), United Kingdom
    • Matthew J. Meiners, CIH, SafeBridge Consultants, Inc., USA
    • Rainer Nicolai, PhD (Co-Lead), F. Hoffmann-La Roche AG, Switzerland
    • George S. Petroka (Co-Lead), IES Engineers, USA
    • Dr. Martin Schöler, Fette Compacting GmbH, Germany
    • Peter Schofield, DEC-USA Inc. & Extract Technology, USA
    • Robert Sussman, PhD, DABT, SafeBridge Consultants, Inc., USA
    • Karen Whitaker, MPH, CIH (Co-Lead), Merck, USA

  • Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition

    • Patrick B. Archer, BWT Pharma, USA
    • Anthony C. Bevilacqua, PhD, Mettler-Toledo Thornton Inc., USA
    • Dr. Nissan Cohen, Biopharm Water Doc, USA
    • Rod Freeman (Co-Lead), Kite Pharma, USA
    • Brian Grochowski, Nuvonic UV, USA
    • Brian Hagopian, CPIP (Co-Lead), Clear Water Consulting, Inc., USA
    • Christopher M. Kwan, Pfizer, USA
    • Wayne Lem, Aquafine/Trojan Technologies, Canada
    • Henk Limpers, Innovatec Gerätetechnik GmbH, Switzerland
    • Joseph Manfredi, GMP Systems, Inc., USA
    • David L. McCarty, Pacific Ozone/Evoqua (retired), USA
    • Stephan Neumann, Boehringer-Ingelheim, Germany
    • Rinke Nijland, Bilthoven Biologicals, The Netherlands
    • Christopher Palte, PE, Agilent Technologies, USA
    • Roque A. Pérez, Johnson & Johnson, USA
    • Brian Pochini, CPIP, Sanofi, USA
    • Michael Rodionov, PEng, PMP, MMR Consulating, Canada
    • Fritz Röder, Merck KGaA, Darmstadt, Germany
    • Jochen Schmidt-Nawrot, CRB Group GmbH, Switzerland
    • Teri C. (T.C.) Soli, PhD, Soli Pharma Solutions, USA
    • Philip E. Sumner, Jr., PE (Co-Lead), Pfizer (retired), USA
    • Sharon Theng, Nuvonic UV, USA
    • Anders Widov, BWT Pharma & Biotech, Sweden
    • Ying Xu, Aquafine/Trojan Technologies, Canada
    • Gary Zoccolante, Plymouth Rock Water Consultants, USA

  • Good Practice Guide: HVAC 2nd Ed 

    • Christopher L. Anderson, PE, CPIP (Co-Lead), Hikma, USA
    • Martina Antalova, BSc, MSc, AstraZeneca, United Kingdom
    • Keith M. Beattie, EECO2 (Energy Efficiency Consultancy Ltd.), United Kingdom
    • Yusuf Bhetasiwala, Encon Expertise Pvt. Ltd., India
    • Colin Dennedy, EWA Controls Ireland Ltd., Ireland
    • Douglas E. Ebert, PE, Eli Lilly, USA
    • Michael Egan, Novo Nordisk, Ireland
    • William (Bill) Gantz, BMS, USA
    • Nick Haycocks, USA
    • Kevin LaPlante, PE, CHA Consulting, Inc., USA
    • Martin McKeon, Novo Nordisk, Ireland
    • Mark Muench, AbbVie, USA
    • Ian Noble, EECO2 (Energy Efficiency Consultancy Ltd.), United Kingdom
    • James A. Quinn, PE, CPIP, CRB Group, USA
    • Edward Rosario, BMS, USA
    • Josh L. Williams, PE (Co-Lead), Genesis AEC, USA

  • GAMP® Good Practice Guide: Computerized GCP Systems & Data 2nd Ed 

    • Geetanjali (Geetu) Abbi, Alkermes, USA
    • Matthew Addis, PhD, Arkivum Limited, United Kingdom
    • Martin Birkfeld, PhD, Bayer AG, Germany
    • George Brunner, Acumen Analytics, Inc., USA
    • Niels De Blende, BLENDED Consulting BV, Belgium
    • Hans de Raad, OpenNovations, The Netherlands
    • Gianna De Rubertis, Montrium, Canada
    • Petch Ashida Druar, Syneos Health, USA
    • David M. Dube, Sarepta Therapeutics, USA
    • Jenny Gebhardt, MD, PhD, MSc, QFINITY Quality Management, Germany
    • Martin Heitmann, d-fine GmbH, Germany
    • Frank Henrichmann (Co-Lead), QFINITY Quality Management, Germany
    • Oliver Herrmann (Co-Lead), QFINITY Quality Management, Germany
    • Matthew Jones, Digital Quality Associates Ltd., United Kingdom
    • Mary Kearns, MSc, MBA, Merck Sharp and Dohme (UK), United Kingdom
    • W. Thomas Koch, WTKoch GCP QA Consulting, LLC, USA
    • Malgorzata Krygier, Roche, Poland
    • Richard Lanyi, Gilead Sciences Inc., USA
    • Prakash Loganathan, GSK, The Netherlands
    • Anubha Mukherjee, Independent Consultant – Compliance and Validation, India
    • Raj Nandhan, Medocity Inc., India
    • Bonnie A. Neuhardt, ElevateBio, USA
    • Mohammed Arif Rahman, OPDC, USA
    • Laila Rasmy, PhD, MSc, MBA, RPh, The University of Texas Health Science, Center McWilliams School of Biomedical Informatics, Egypt/USA
    • Raymond A. Roggero, Medvacon Life Sciences, USA
    • Katherine A. Rohrbach, Syneos Health, USA
    • Marcus Schwabedissen, QFINITY Quality Management, Germany
    • Doug Shaw, DShaw Consulting, LLC, USA
    • Paul A. Smith, Compliance2425, United Kingdom
    • Anna Dachs Soler, PhD, AMBIT-BST, Spain
    • Brandi M. Stockton, The Triality Group, LLC, USA
    • Maximilian Stroebe, PhD (Co-Lead), Janssen Vaccines & Prevention, The Netherlands
    • Thanabalan Subramanian, ProductLife Group, United Kingdom
    • Christian Thomsen, MSc, LEO Pharma A/S, Denmark
    • Jean-Francois J. Vanberg, IDDI, Belgium
    • Roy Verhoeven, Vivenics, The Netherlands
    • Lorrie L. Vuolo-Schuessler, GSK, Syneos Health (Retired), USA
    • Johan George Wasserman, Parexel International, South Africa

  • Good Practice Guide: Unique ID of Glass Primary Containers

    • Alexander Bauer, Boehringer Ingelheim, Germany
    • Andreas Böhme, Körber Pharma Inspection, Germany
    • Francesco Brazzarola, Antares Vision SpA, Italy
    • Maria Victoria De La Torre, SCHOTT Pharma AG & Co. KGaA, Germany
    • Tobias Dombrowski, groninger GmbH & Co. KG, Germany
    • Laurent Fleuret (Co-Lead), GSK Biopharm, Belgium
    • Arno Fries, PhD, Nipro PharmaPackaging International N.V., Belgium
    • Maurizio Grassi, IMA, Italy
    • Yacine Haddadi, BD, France
    • Sumant Kapoor, APKID, India
    • Gregor Kotyrba, PhD, KTS GmbH, Germany
    • Robert Lindner, PhD, SCHOTT Pharma Schweiz AG, Switzerland
    • Daniel Martinez, Stevanato Group SpA, Italy
    • Bruno Morchain, Aptar Pharma, France
    • Mario Nagler, Groninger & Co. GmbH, Germany
    • Joseph P. O’Connor, Eli Lilly & Co., USA
    • Alessandro Pelizzi (Co-Lead), LifeBee | A ProductLifeGroup Company, Italy
    • Louis Petit, Becton Dickinson, France
    • Damiano Pierro, Merck, Italy
    • Federico Piutti, Bormioli Pharma, Italy
    • Thierry Protas, Jekson Vision Ltd., France
    • Alberto Reghenzi, Antares Vision, Italy
    • Armin Rehberger, Bausch + Ströbel SE + Co. KG, Germany
    • Rudolf Renfurm, Agillox Benelux BV, The Netherlands
    • Andrea Sardella, PhD, Stevanato Group SpA, Italy
    • Johannes Selch, GEA Lyophil GmbH, Germany
    • Herve Soukiassian, BD, France
    • Daniel Sturm, Syntegon Technology, Germany
    • Tod Urquhart (Co-Lead), CIM A/S, United Kingdom
    • Jens Vanneste, Alcon Couvreur NV, Belgium
    • Sabine Wohlfart, Gerresheimer Regensburg GmbH, Germany
    • Michele Zanin, Brevetti CEA SpA, Italy

  • Guide: 503A Compounding

    • Authoring team from Lachman Consultant Services, Inc., led in large part by Becky Welton. MY SEARCHES | SAVED SEARCHES

  • ISPE Guide: ATMPs – Allogeneic Cell Therapy

    • Jose Caraballo-Orama, Kite, a Gilead Company, USA
    • Pinar Cicalese, PhD, Immatics, USA
    • Norman Goldschmidt, Genesis AEC, USA
    • Komal Hatti, NCARB, LEED AP (Co-Lead), IPS, USA
    • Niranjan Kulkarni, PhD, CRB, USA
    • Ian Moy (Co-Lead) Catalent, USA
    • Emilie Pelletier, Orchestra Life Sciences USA
    • Erik Steffensen (Co-Lead), Spot-on Pharma Consulting, Denmark
    • Daniel Swanson, PE, IPS, USA
    • Biana Torres, Encoded Therapeutics, USA

  • ISPE Guide: ATMPs – rAAV Comparability and Lifecycle Management

    • Lucile Bessueille (Co-Lead), Hoffmann-La Roche AG, Switzerland
    • Ben Clarke, PhD, US Pharmacopeia, USA
    • Jasna Curak, F. Hoffmann-La Roche Ltd, Canada
    • Zhimei Du, Landmark Bio, USA
    • Paul Fiorio, Bayer AG, Switzerland
    • Michael Gorman, Vertex Pharmaceuticals, USA
    • Catherine Jomary, PhD, IPS-Integrated Project Service GmbH, Switzerland
    • Michael LeCompte, LeCompte Biopharma Consulting, USA
    • John MacNair, Spark Therapeutics, USA
    • Aaron Miller, Denali Therapeutics, USA
    • Apurv Puri, Pharmatech Associates, USA
    • Nessiem Samuel, CQE, SSGB, GxP Impact Consulting LLC, USA
    • George Todorov (Lead), IPS-Integrated Project Services, LLC, USA
    • Natalie Ward, PhD, Adaptimmune, United Kingdom

  • ISPE Baseline® Guide: Pharma 4.0™ 

    • Nuha Al-Hafez, Roche, Canada
    • Rolf Blumenthal, Körber Pharma Software, Germany
    • Michelangelo Canzoneri (Co-Lead), Merck KGaA Darmstadt, Germany
    • Richard Denk, SKAN, Switzerland
    • Yvonne Duckworth, PE, CRB, USA
    • Jean-Francois Duliere, ISPE Regulatory Advisor, France
    • Matt Edwards, CRB, USA
    • Rene-Pascal Fischer, Fraunhofer IESE, Germany
    • Thomas Friedli, University of St.Gallen, Switzerland
    • Vincent Gerber, F. Hoffmann-La Roche AG, Switzerland
    • Mark Grothkopp, University of St.Gallen, Switzerland
    • Lothar Hartmann, PhACT GmbH, Switzerland
    • Bryon Hayes, Grantek, Canada
    • Emmie Heeren, Kite Pharma Inc., Netherlands
    • Christoph Herwig, Körber Pharma Austria, GmbH, Austria
    • Kim Hewson, GSK, United Kingdom
    • Rod Hoffman, AstraZeneca, USA
    • Daniele Iacovelli (Co-Lead), Hoffmann-La Roche AG, Switzerland
    • Rob Innes, Wyoming Interactive, United Kingdom
    • Keegan Johnson, Siemens SI, USA
    • Paige Kane, PhD, Merck & Co., Inc., USA
    • Philipp Kläsle, Körber Pharma Consulting, Germany
    • Stefan Krauss, Siemens AG, Germany
    • Gilad Langer, Tulip Interfaces, USA
    • Line Lundsberg-Nielsen, Lundsberg Consulting, Denmark
    • Giuseppe Menin, COPA-DATA, Italy
    • Teresa Minero, LifeBee, Italy
    • Christine M.V. Moore, , USA
    • Bill Reid, Google, USA
    • Heike Röder, Cencora, Germany
    • Edoardo Schiraldi, Menarini, Italy
    • Davide Smaldone, Kenvue , Italy
    • Josef Trapl (Co-Lead), Memo3 GmbH, Switzerland
    • Joost Van Den Broeck, Sanofi, Belgium
    • Jörn Volckmann, FrontWell Solutions GmbH, Germany
    • Michelle Vuolo, Tulip Interfaces, USA
    • Stephen Wing, MilliporeSigma, USA
    • Wolfgang Winter, Agilent Technologies, Germany
    • Christian Wölbeling (Co-Lead), Körber Pharma Software, Germany
    • Dirk Wollaert, Siemens, Belgium
    • Stefan Wurzer, F. Hoffmann-La Roche AG, Switzerland
    • Zen-Zen Yen, Bayer AG, Germany
    • Thomas Zimmer, ISPE, Germany

  • ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities 3rd Edition

    • Ronald Berk, Hyde Engineering + Consulting Inc., USA
    • Erich H. Bozenhardt, United Therapeutics, USA
    • Jose A. Caraballo-Oramas, Kite Pharma, a Gilead Company, USA
    • Carl Carlson, Genesis AEC, USA
    • Manuel Castro Pires, Merck KGaA, Spain
    • Vince Cebular, IPS – Integrated Project Services, USA
    • Peter W. Cramer, AIA, Jacobs Engineering, USA
    • Robert Dream, HDR Company LLC, USA
    • Cheryl Essex, Sanofi, USA
    • David Estapé, PhD, CRB Group GmbH, Switzerland
    • Norman A. Goldschmidt, Genesis AEC, USA
    • Christoph Herwig, PhD, Körber Pharma, Austria
    • Grace Linton, CRB, USA
    • John L. Machulski, Catalent, USA
    • Jeffrey N. Odum, CPIP (Co-Lead), Genesis AEC, USA
    • Marc P. Pelletier, PhD, CRB, USA
    • Brian Pochini, CPIP (Co-Lead), Sanofi, USA
    • James A. Quinn, PE, CPIP, DPS Engineering, USA
    • Sander Thijssen, MSD (Merck), The Netherlands
    • Mark von Stwolinski, RA, CRB, USA
    • Kelly Waldron, PhD, ValSource, Inc., USA

  • ISPE Good Practice Guide: Process Gases 2nd Edition 

    • Nissan Cohen, PhD (Co-Lead), Biopharmaceutical Water Doc, USA
    • Rod Freeman, Kite Pharma, USA
    • Ariel Kehati, Johnson & Johnson, Israel
    • Thorsten Klein, BEKO Technologies GmbH, Germany
    • Eric Kuntzmann, Pharmaplan, Switzerland
    • Christopher M. Kwan, Pfizer, USA
    • Henrik Mathiesen, Novo Nordisk A/S, Denmark
    • Martin McKeon, Alkermes, Ireland
    • Stephan Neumann (Co-Lead), Boehringer Ingelheim, Germany
    • Rinke Nijland, MSD Biotech Oss, The Netherlands
    • Ruby Ochoa, Trace Analytics, USA
    • Brian Pochini, CPIP, Sanofi, USA
    • Fritz Roeder, Merck Healthcare KGaA, Germany
    • Kimball Shahrokhi, PE, Jacobs Engineering USA
    • John V. Welbourn, Compliance and Validation Services Ltd., United Kingdom

  • ISPE Good Practice Guide: Containment for Potent Compounds 

    • Marc W. Abromovitz, Novartis Pharmaceutical Corporation, USA
    • Dirk Collins, Hermann Waldner GmbH & Co. KG, Germany
    • Malcolm Cunningham, Chargepoint Technology, United Kingdom
    • Richard Denk, SKAN AG, Switzerland
    • Dave Eherts, PhD, CIH, National Safety Council, USA
    • Jeffrey A. Fedor, CRB Consulting Engineers, Inc., USA
    • Dr. Andreas Flückiger, Andreas Flückiger Consulting Switzerland
    • Oliver Gottlieb, NNE, Denmark
    • Reinhard Uwe Hahmann, HET Filter GmbH, Germany
    • Dr. Friederike Hermann, Lonza AG, Switzerland
    • Kolja Klein, Pharmaplan, Switzerland
    • Glenn F. Lawrence (Co-Lead), Merck & Co. (retired), USA
    • Dr. Reinhold Maeck (Co-Lead), Boehringer Ingelheim Corporate Center GmbH, Germany
    • Peter James Marshall, AstraZeneca (retired), United Kingdom
    • Matthew J. Meiners, Bureau Veritas, USA
    • Dr. Rainer Nicolai (Co-Lead), F. Hoffmann-La Roche Ltd., Switzerland
    • Martin Pernau, Bayer AG, Germany
    • George S. Petroka (Co-Lead), IES Engineers USA
    • Charlyn Reihman, MPH, CIH, Safebridge Consultants, Inc. USA
    • Dr. Martin Schöler, Fette Compacting GmbH, Germany
    • Peter Schofield, Extract Technology (part of the Dec group), USA
    • Robert Sussman, PhD, SafeBridge Consultants, Inc., USA

  • ISPE APQ Guide: Cultural Excellence 

    • Maria Amaya, Genentech, A Member of the Roche Group, USA
    • Erika Ballman (Co-Lead), Perrigo, USA
    • Nuala Calnan, PhD (Co-Lead), BioPharm Excel Ltd., Ireland
    • Robert Brian Cutler, Jr., Johnson & Johnson, USA
    • Tami Frederick (APQ Advisor), Perrigo, USA
    • Apneet Hayer, F. Hoffman-LaRoche, Canada
    • Harry Jeffreys, Bausch + Lomb Inc, USA
    • Christine Teipen Smith, Eli Lilly & Company, USA

  • APQ Guide: Process Performance and Product Quality Monitoring System

    • Theresa Allyn, F. Hoffmann-La Roche, Canada
    • Maneesha Altekar, PhD, AstraZeneca, USA
    • Rafael Beerbohm, PhD, Boehringer Ingelheim, Germany
    • Tami Frederick (APQ Advisor), Perrigo Co., USA
    • Bethany Glyde, Viatris, USA
    • Eric Kwei, Amgen, USA
    • Line Lundsberg-Nielsen, PhD (Co-Lead), Lundsberg Consulting Ltd., United Kingdom
    • Georgina McLeod, PhD, AbbVie Inc., USA
    • Ingrid Rodriguez Soto, AbbVie Inc., USA
    • Maurice Parlane, New Wayz Consulting Ltd./CBE Pty. Ltd., New Zealand
    • Cenk Undey, PhD, Genentech, USA
    • Christian Wölbeling (Co-Lead), Körber Pharma Software, Germany

  • ISPE GAMP® 5 2nd Edition

    • Sam Andrews, Novartis, United Kingdom
    • Karen Ashworth, Karen Ashworth Consulting Ltd., United Kingdom
    • Carsten Bierans, Körber Pharma Software, Germany
    • James Canterbury, Ernst and Young LLP, USA
    • Mark Cherry, AstraZeneca, United Kingdom
    • Chris Clark (Co-Lead), TenTenTen Consulting Limited, United Kingdom
    • Stephen R. Ferrell, CompliancePath (an Ideagen Company), USA
    • James Gannon, PharmaLedger Association, Ireland
    • Senthil Gurumoorthi, Amazon, USA
    • Robert Hahnraths, Bayer, Germany
    • James Henderson, Eli Lilly and Company, USA
    • Frank Henrichmann, QFINITY, Germany
    • Oliver Herrmann, QFINITY, Germany
    • David Samuel Holt, Factorytalk Co., Ltd., Thailand
    • Paul Irving, Northern Life Sciences Ltd., United Kingdom
    • Torsten Isenberg, Körber Pharma Software, Germany
    • Paige Kane, PhD, Merck & Co., Inc., USA
    • David Margetts, Factorytalk Co., Ltd., Thailand
    • Andrew McDonagh, Emergn, United Kingdom
    • Elizabeth McLellan, Suvoda, USA
    • Sandy Meek, Parexel, United Kingdom
    • Khaled Moussally, Compliance Group Inc., USA
    • Ray Murphy, Boston Scientific, Ireland
    • Mark E. Newton, Heartland QA, USA
    • Donal O’Brien, Dassault Systèmes, Ireland
    • Arthur D. Perez, PhD, Novartis (retired), USA
    • Margrét Pétursdóttir, Alvotech, Iceland
    • Rajdeep Poddar, Novartis Healthcare Pvt. Ltd., India
    • Chris Reid, Integrity, United Kingdom
    • Edgar Röder, PricewaterhouseCoopers, Germany
    • Gregory Ruklic, GMR Consultants, USA
    • Michael L. Rutherford, Syneos Health, USA
    • Judith S. Samardelis, GSK, USA
    • Levi Schenk, CSL Behring, USA
    • Lorrie Vuolo-Schuessler, Syneos Health, USA
    • Tanya Sharma, Assurea, LLC, USA
    • Ken Shitamoto, Gilead, USA
    • Eric J. Staib, Signant Health, USA
    • Brandi M. Stockton, Signant Health, USA
    • Thana Subramanian, Integrity, United Kingdom
    • Charlie Wakeham, Waters Corporation, Australia
    • Heather Watson (Co-Lead), GSK (retired), United Kingdom
    • Christopher H. White, National Resilience, Inc., USA
    • Tomos Gwyn Williams, Manchester Imaging, United Kingdom
    • Guy Wingate, GSK (retired), United Kingdom
    • Christian Wölbeling, Körber Pharma Software, Germany
    • Sion Wyn (Co-Lead), Conformity Ltd., United Kingdom

  • ISPE Good Practice Guide: Membrane-Based WFI Systems 

    • Patrick Archer, BWT Pharma & Biotech, USA
    • Nissan Cohen, Biopharmaceutical Water Doc, USA
    • Brian Cox, Eli Lilly and Company, USA
    • Jamie Evans, Grifols Canada Therapeutics, Canada
    • Michelle M. Gonzalez, PE, BioPharm Engineering Consulting, Inc., USA
    • Brian Hagopian, CPIP, Clear Water Consulting, Inc., USA
    • Philip R. Horstmeyer, Eli Lilly and Company, USA
    • Ariel Kehati, Omrix Biosurgery, J&J, Israel
    • Kevin Kloet, Cheme Engineering Inc., Canada
    • Nik Krpan, Cheme Engineering Inc., Canada
    • Paolo M. Leani, Stilmas S.p.A., Italy
    • Joseph Manfredi, GMP Systems, Inc., USA
    • Stephan Neumann, Boehringer Ingelheim, Germany
    • Rinke Nijland, MSc, MSD Biotech Oss, Netherlands
    • Chris Peterson, AbbVie, USA
    • Brian Pochini, CPIP, (Co-Lead), Sanofi, USA
    • Stefan Raabe, Endress+Hauser (Schweiz) AG, Switzerland
    • Michael Richter, Boehringer Ingelheim, Germany
    • Fritz Röder, (Co-Lead), Merck Healthcare KGaA, Germany
    • Jochen Schmidt-Nawrot, CRB Group GmbH, Switzerland
    • Teri C. (T.C.) Soli, PhD, Soli Pharma Solutions, Inc., USA
    • Philip E. Sumner Jr, PE, Pfizer Inc., USA
    • Scott H. Walker, Eli Lilly and Company, USA
    • John Wammes, CPIP, Water Works Inc., USA
    • David Weller, GTec GmbH Wasseraufbereitung, Germany
    • Anders Widov, MSc, BWT Pharma & Biotech, Sweden
    • Mike Wojcik, MECO, A Grundfos Company, USA
    • Marcel Zehnder, BWT Aqua AG, Switzerland
    • Gary V. Zoccolante, Plymouth Rock Water Consultants, USA

  • Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

    • Robert Axelsson, AstraZeneca, Sweden
    • Ivo Backx, Siemens AG, Belgium
    • Roger A. Barnum, Jenike & Johanson Inc., USA
    • Thomas Baxter, Vertex Pharmaceuticals, Inc., USA
    • Guia Bertuzzi, IMA S.p.A., IMA Active Division, Italy
    • Ivan Bogaerts, GEA Process Engineering NV, Belgium
    • Alexandre Bonnassieux, Vertex Pharmaceuticals Inc., USA
    • Jenna K. Brandon, Pfizer Inc., USA
    • Paul Brodbeck, Continua Process Systems, USA
    • Stefan Busche, PhD, Merck Healthcare KGaA, Germany
    • Gregory Connelly, PhD, (Co-Lead) ,Vertex Pharmaceuticals, Inc., USA
    • Steven Dale, Vertex Pharmaceuticals, Inc., USA
    • Ranjit M. Dhenge, GlaxoSmithKline, United Kingdom
    • Eric Dinarello, Vertex Pharmaceuticals, Inc., USA
    • Dave DiProspero, (Co-Lead), CRB, USA
    • David Egan, Pharmaceutical Manufacturing Technology Centre, University of Limerick, Ireland
    • Richard Elkes, GlaxoSmithKline, United Kingdom
    • Nicola Gandolfi, IMA SpA, Italy
    • Dr. Sudarshan Ganesh, Applied Materials, Inc., USA
    • Joshua M. Hanson, Eli Lilly and Company, USA
    • Douglas B. Hausner, PhD, Thermo Fisher Scientific, USA
    • Theresa Hörmann-Kincses, RCPE, Austria
    • Rachelle Howard, PhD, Vertex Pharmaceuticals, Inc., USA
    • Eric Jayjock, PhD, CONTINUUS Pharmaceuticals, USA
    • Johannes Khinast, TU Graz & RCPE, Austria
    • Ashish Kumar, Ghent University, Janssen Pharmaceutica, Belgium
    • Bob Lenich, Emerson Automation Solutions, USA
    • John C. Lewis, PE, IPS, USA
    • Ryan J. McCann, PhD, AstraZeneca, USA
    • Dr. Robin Meier, L.B. Bohle Maschinen und Verfahren GmbH, Germany
    • Dr. Marc Michaelis, Hüttlin GmbH, a Syntegon company, Germany
    • Marco Minardi, IMA SpA, Italy
    • Dr. Bart Nitert, Janssen, Belgium
    • Ronald Ruff, Eli Lilly and Company, USA
    • Stephan Sacher, RCPE, Austria
    • Barbara E. Schaller, University of Limerick, Ireland
    • Dr. Sandra Stranzinger, Research Center Pharmaceutical Engineering, Austria
    • Anthony S. Tantuccio, Hovione LLC, USA
    • Andreas Teske, L.B. Bohle Maschinen und Verfahren GmbH, Germany
    • Sridhar Valluri, BMS (Bristol-Myers Squibb), USA
    • Jan Verelst, Siemens NV, Belgium
    • Laura Wareham, Merck & Co., Inc., USA

  • ISPE APQ Guide: Change Management System

    • Lori Chelemedos (Lead), Pac-Side LLC, USA
    • Andrew Denny, Bristol-Myers Squibb, USA
    • Denise DiGiulio, Johnson & Johnson, USA
    • Tami Frederick (APQ Advisor), Perrigo, USA
    • Tim Huber, Eli Lilly & Co., USA
    • Harry Jeffreys, Bausch Health Companies, USA
    • Jennifer Peszek, Pfizer Inc., USA
    • Clayton Lee Spillman, Pfizer Inc., USA
    • Jo Anne Valentino, Minaris Regenerative Medicine, USA

  • ISPE Good Practice Guide: Controlled Temperature Chambers 2nd Edition

    • Mike Bradley (Co-Lead), Finch Therapeutics Group, Inc., USA
    • Dean Rainbolt (Co-Lead), Thermo Fisher Scientific, USA)
    • Luca Arrighi, Wood PLC, Italy
    • Paul Daniel, Vaisala Inc., USA
    • Abhishek Garg, IPS, Canada
    • Derek Moss, Fujifilm Diosynth Biotechnologies, USA
    • Dinora Najera, Novartis, USA
    • Sarah Pegington-Chow, NHS Blood and Transplant, United Kingdom
    • Nathan Roman, Genesis Engineers AEC, USA
    • James Swann, Seqirus, United Kingdom
    • Shadreck Tasiyana, Varichem Pharmaceuticals Pvt. Ltd., Zimbabwe

  • ISPE Guide: ATMPs – Autologous Cell Therapy

    • Tom Bannon, PM Group, Ireland
    • Phil Baratta, Project Farma, USA
    • Erich Bozenhardt, United Therapeutics, USA
    • Jose A. Caraballo, Kite Pharma, a Gilead Company, USA
    • Vince Cebular, IPS – Integrated Project Services, USA
    • Pinar Cicalese, Immatics, USA
    • Bruce Davis, BD Global Consulting, United Kingdom
    • Lesley Davis, Project Farma, USA
    • Andrew Doppstadt, Project Farma, USA
    • Paul Fleming, PMP, Roche Genentech, USA
    • Norman Goldschmidt, Genesis AEC, USA
    • Christoph Herwig, Vienna University of Technology, Austria
    • Niranjan Kulkarni, PhD, CRB, USA
    • Arantxa Lera Anton, PM Group, Ireland
    • Jeff Odum (Lead), CPIP, NC Biosource, USA
    • Emilie Pelletier, Iovance Biotherapeutics, USA
    • Brian Pochini, Sanofi, USA
    • Prof. Dr. Christa Schröder, Fakultät Life Sciences, Germany
    • Aaron Weinstein, IPS – Integrated Project Services, USA

  • ISPE Good Practice Guide: Good Engineering Practice 2nd Edition

    • Chip Bennett (Co-Lead), CAI, USA
    • Joerg Block (Co-Lead), Bayer AG, Germany
    • Mark Drinan, Takeda Pharmaceuticals International AG, Switzerland
    • Fabio Gentilini, Catalent Pharma Solutions, Italy
    • Taha Jalal, Freelance Engineer, Switzerland
    • Glenn Lawrence, Merck (retired), USA
    • Craig Milner, PM Group, United Kingdom
    • Mark Muench, AbbVie Inc., USA
    • Midhu Varghese, AbbVie Inc., USA
    • Stephanie White, Amgen Inc., USA
    • Steve Wisniewski, CAI, USA

  • ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management 

    • Karen Ashworth, Karen Ashworth Consulting Ltd., United Kingdom
    • Carsten Bierans, Körber Business Area Pharma, Germany
    • Mark Cherry, AstraZeneca, United Kingdom
    • Chris Clark (Co-Lead), TenTenTen Consulting Limited, United Kingdom
    • Stephen Ferrell, Compliance Path Ltd., USA
    • James Gunning, Johnson Matthey, USA
    • Frank Henrichmann, QFINITY, Germany
    • Oliver Herrmann, QFINITY, Germany
    • Paul James-Martin, Integrity Project Solutions Limited, United Kingdom
    • Kevin C. Martin, Azzur Group LLC, USA
    • Andrew McDonagh, Emergn, United Kingdom
    • Elizabeth McLellan, Suvoda, LLC, USA
    • Khaled Moussally, Compliance Group, USA
    • Ray Murphy, Boston Scientific, USA
    • Donal O’Brien, Dassault Systèmes, Ireland
    • Michael Osburn, Cornerstone OnDemand, USA
    • Randy Perez, Novartis (retired), USA
    • Chris Reid, Integrity Solutions Limited, United Kingdom
    • Mike Rutherford, Syneos Health, USA
    • Judith Samardelis, Syneos Health, USA
    • Jens Seest, Novartis, Germany
    • Ken Shitamoto, Gilead Sciences, Inc., USA
    • Andy Tyrrell, Cornerstone OnDemand, United Kingdom
    • Anders Vidstrup, NNIT A/S, Denmark
    • Lorrie Vuolo-Schuessler, Syneos Health, USA
    • Charlie Wakeham, Waters Corporation, Australia
    • Mark Walton, Cornerstone OnDemand, United Kingdom
    • Heather Watson (Co-Lead), GlaxoSmithKline, United Kingdom
    • Anette Westphal, Novo Nordisk A/S, Denmark
    • Christopher White, National Resilience, Inc., USA
    • Guy Wingate, GlaxoSmithKline, United Kingdom
    • Sion Wyn (Co-Lead), Conformity Ltd., United Kingdom

  • ISPE Good Practice Guide: IMP Reverse Logistics – Good Returns and Reconciliation Practices 

    • Neal A. Gordon, PhD, Merck & Co., Inc., USA
    • Edward Groleau, PCI Pharma Services, USA
    • Catherine (Cat) Hall, MS, MBA, endpoint Clinical, USA
    • Greg Hottell GSK, USA

  • ISPE APQ Guide: Management Responsibilities and Management Review

    • Tisha Cromwell, Catalent Pharma Solutions, USA
    • Tami Frederick (APQ Advisor), Perrigo, USA
    • Marci Goldfinger, Johnson & Johnson, USA
    • Steven Greer (Co-Lead), ESi and Procter & Gamble, USA
    • Michael Grischeau (Co-Lead), AbbVie Inc, USA
    • Robert Matje, RemTech LLC, USA
    • Lorraine McClain, Nabriva Therapeutics, USA
    • Jo Anne Valentino, Minaris Regenerative Medicine, USA
    • Veda K. Walcott, Catalent Pharma Solutions, USA
    • Bryan Winship, Lonza, USA

  • ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry 

    • Patrick Blacha, Eli Lilly & Company, USA
    • Melanie Byrne (Co-Lead), Pfizer, Ireland
    • Nuala Calnan, PhD, Biopharm Excel Ltd., Ireland
    • Stephanie Friedrichsen, Eli Lilly & Company, USA
    • Anne Greene, PhD, Technological University Dublin, Ireland
    • Frank Hallinan, PhD, Quality System Support, Ireland
    • Paige Kane, PhD (Co-Lead), Merck & Co., Inc., USA
    • M. Narendira Kumar, Dr. Reddy’s Laboratories, India
    • Marty Lipa, MS, Merck & Co., Inc., USA
    • Ahmed Ramy, PhD, Mylan, Ireland

  • ISPE Good Practice Guide: Maintenance 2nd Edition

    • Dan Franklin, IPS, USA
    • Thomas Harris, AstraZeneca, USA
    • Michael Lacey, West Pharmaceutical Services, Ireland
    • Tim Lai, Boehringer Ingelheim, USA
    • Stephan Neumann, Boehringer Ingelheim GmbH, Germany
    • Peniel Ortega (Co-Lead), PharmAllies, USA
    • Constantino Rodriguez (Co-Lead), Catalent Cell & Gene Therapy, USA
    • Hamid Teimourian, AstraZeneca, USA
    • Alfred Ao Yu, Resilience Biotechnologies Inc., Canada

  • ISPE Good Practice Guide: Equipment Reliability 

    • Michael Berkey (Lead), Merck & Co., Inc., USA 
    • John Byrne, MSD, Ireland 
    • Thomas Harris, AstraZeneca, USA 
    • Robert Smith, CAI, USA 
    • Hamid Teimourian, AstraZeneca, USA 
    • Richard Tree, CAI, USA 
    • Alfred Ao Yu, Resilience Biotechnologies Inc., Canada 

  • ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System 

    • Lori Chelemedos (Co-Lead), Independent Consultant, Regulatory Compliance, USA
    • Andrew Denny, Bristol-Myers Squibb, USA
    • Kira Ford (Co-Lead), Eli Lilly, USA
    • Tami Frederick (Co-Lead), Perrigo, USA
    • Ketan Gujarathi, Bristol-Myers Squibb, USA
    • Blaine Spangler, Baxter Healthcare, USA

  • ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design

    • Petch Ashida-Druar, GlaxoSmithKline, USA
    • Matt Brawner, Data Integrity and Compliance Consultant, USA
    • Roger Buchanan, Buchanan Consultancy Ltd., United Kingdom
    • Rob Dillman, Eli Lilly & Company, USA
    • James Henderson (Co-Lead), Eli Lilly and Company, USA
    • Stuart Jones, Merck & Co. Inc., Ireland
    • Paige Kane, Merck & Co. Inc., USA
    • Heather Longden, Waters Corporation, USA
    • Charles H. Maher III, CAI, USA
    • Bob McDowall, R D McDowall Ltd., United Kingdom
    • Matt McMenamin, GlaxoSmithKline, USA
    • Anubha Mukherjee, CSV and IT Compliance Consultant, India
    • Mark Newton, Heartland QA, USA
    • Levi Schenk, CSL Behring, USA
    • Rob Stephenson, Rob Stephenson Consultancy, United Kingdom
    • Lorrie Vuolo-Schuessler (Co-Lead), Syneos Health, USA
    • Charlie Wakeham (Co-Lead), Waters Corporation, Australia

  • ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls 

    • Jose Caraballo (Co-Lead), Bayer U.S., USA
    • Liz Dallison, Pfizer Ltd., United Kingdom
    • Rich Forsyth, Forsyth Pharmaceutical Consulting, USA
    • Trefor Jones, Bluehatch Consultancy Ltd., United Kingdom
    • Beth Kroeger-Fahnestock, STERIS Corp., USA
    • Sam Lebowitz, Electrol Specialties Co., USA
    • Catherine Oakes, Oakes Group Global, Turkey/USA
    • Fred Ohsiek, Novo Nordisk, USA
    • Joseph Payne (Co-Lead), Tergus Pharma (formerly with Alcami Corp.), USA
    • David W. Vincent, MPH, PhD, VTI Life Sciences, Inc., USA/Asia

  • ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It 

    • Robert M. Augustine, Eli Lilly and Company, USA
    • Brian Cox, Eli Lilly and Co., USA
    • Stuart du Kamp, Innomar Strategies Inc., Canada
    • W. Roderick Freeman (Co-Lead), Kite Pharma, Inc., USA
    • Ariel Kehati, Johnson & Johnson, Israel
    • Nik Krpan (Co-Lead), Cheme Engineering Inc., Canada
    • Joe Manfredi, GMP Systems, Inc., USA
    • Dave Manku, Azzur Group LLC, USA
    • Samuel O’Callaghan, CSL Behring, USA
    • Fritz Röder, Merck Healthcare KGaA, Germany
    • Teri C. Soli, PhD, Soli Pharma Solutions Inc., USA
    • Roland Thoendel, Takeda, Austria
    • Nancy Tomoney, Strategic Solutions, USA

  • ISPE Good Practice Guide: HVAC and Process Equipment Air Filters 

    • Chris Barbieri, PE, CRB, USA
    • Rahul Bharadwaj, Lydall, USA
    • Eugene Bryan, Milholland & Associates, USA
    • Kimberly Coughlin, Kastango Consulting Group, LLC, USA
    • Steve Devine, Camfil USA, USA
    • William Gantz, Bristol-Myers Squibb, USA
    • Dean Hale, Eli Lilly & Co., USA
    • Nick Haycocks (Co-Lead), Amgen Inc., USA
    • Don Largent, Air Techniques International, USA
    • Dan Milholland (Co-Lead), Milholland & Associates, USA
    • Donald Moore (Co-Lead), Process Alliance, USA
    • Sean O’Reilly, AAF Flanders, USA
    • Mike Osborne, AAF Flanders, USA
    • David Phillips, Thermo Fisher Scientific, USA
    • Ron Roberts, Bayer Healthcare, USA
    • Hasim Solmaz, Lighthouse Worldwide Solutions, Turkey
    • Andy Stillo, Camfil USA, USA
    • Don Thornburg, Camfil USA, USA
    • Lisa Warner, Camfil USA, USA
    • Shawn Windley, AAF Flanders, USA

  • ISPE Good Practice Guide: Asset Management 

    • Michael Anderson, CMRP, Life Cycle Engineering, USA
    • Matthew J. Baldwin, Novo Nordisk, USA
    • Steve Bryan, AstraZeneca, United Kingdom
    • Michael S. Cheney, Biogen Idec, USA
    • John S. Hughes, CAI, USA
    • Scott D. Morris (Co-Lead), Sanofi, USA
    • Stephen E. O’Brien, Pfizer Inc., USA
    • Dr. Phillip Richardson, AstraZeneca, United Kingdom
    • Robert Smith (Co-Lead), International Isotopes Inc., USA

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

    • Robert M. Augustine, Eli Lilly and Company, USA
    • Andrew Baird, Jacobs Engineering, USA
    • Anthony Bevilacqua, PhD, Mettler-Toledo Thornton Inc., USA
    • Nissan Cohen (Co-Lead), Biopharmaceutical Water Doc, USA
    • Robert C. Coleman, IHL Consulting Group, Inc., USA
    • Martin Emery, AveXis, USA
    • Jamie Evans, GC Biotherapeutics, Canada
    • Diana Fischer, Bausch & Lomb, Inc., USA
    • W. Roderick Freeman, Kite Pharma, USA
    • Michelle Gonzalez, Amgen Inc. (retired), USA
    • Brian Hagopian, CPIP, Clear Water Consulting Inc., USA
    • Ariel Kehati, Omrix, Johnson & Johnson, Israel
    • Joseph Manfredi, GMP Systems, Inc., USA
    • Brian McClellan, Aqua-Chem Inc., USA
    • Chris Peterson, AbbVie, USA
    • Brian Pochini, CPIP (Co-Lead), Sanofi, USA
    • Shlomo Sackstein, Biopuremax Ltd., Israel
    • Ian Shanahan, MECO Ireland Ltd., Ireland
    • T.C. Soli, PhD, Soli Pharma Solutions Inc., USA
    • Philip E. Sumner, Pfizer Global Engineering, USA
    • Roland Thoendel, Takeda, Austria
    • John Walker, VWS/Elga, United Kingdom
    • Paul Whitehead, PhD, VWS/Elga (retired), United Kingdom
    • Anders Widov, Wiphe AB, Sweden
    • Steve Wisniewski, CAI, USA
    • Gary Zoccolante (Co-Lead), Plymouth Rock Water Consultants, USA

  • ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition)

    • Chris Ames (Co-Lead), Akebia Therapeutics Inc., USA 
    • Tiffany Baker, ValSource, USA 
    • Joerg Block, PhD, Bayer AG, Germany 
    • Ronald Brunelle, Amgen, Inc., USA 
    • Graham Cameron, GlaxoSmithKline, UK 
    • Peter Werner Christensen, Cook Medical, Denmark 
    • Hazem Eleskandarani, PE, Johnson & Johnson, USA 
    • Nick Haycocks (Co-Lead), Amgen, Inc. , USA 
    • Lori Kim, AbbVie, USA 
    • Glenn Lawrence, Independent Pharm Consultant (Merck & Co. – retired), USA 
    • Bob Myers (Co-Lead), Pfizer Inc., USA 
    • Xavier Pieri, GlaxoSmithKline Vaccines, Belgium  
    • Alice Redmond, CAI, Ireland 
    • Mark E. Rezac, PE (Co-Lead), Integrated Project Services, LLC, USA 
    • Ramon Ruiz Quinones, Merck & Co., Inc., USA 
    • Ghenet Simpson, GlaxoSmithKline, USA 
    • Frank van der Steen, FVCS, Netherlands  
    • Michelle Whipple, Rentschler Biopharma Inc., USA 
    • Steven Wisniewski (Co-Lead), CAI, USA 

  • ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records

    • John Andrews, Andrews Consulting Enterprises, Ltd., United Kingdom
    • Karen Ashworth, Karen Ashworth Consulting, Ltd., United Kingdom
    • Reetu Chopra, Teva Pharmaceutical Industries, Ltd., United Kingdom
    • Kristina Dimitriadis, Werum IT Solutions GmbH, Germany
    • Brian Frederiksen, NNE, Denmark
    • Željko Granoša, Pliva Croatia, Ltd., Croatia
    • Paul Irving, Northern Life Sciences Ltd., United Kingdom
    • Hilary Mills-Baker, Emerson Automation Solutions, United Kingdom
    • Steve Murray, Werum IT Solutions, USA
    • Gregory Ruklic, Independent Consultant, USA
    • Catherine Smillie, Sharpe Solutions & Compliance Ltd., United Kingdom
    • David Stokes, Convalido Consulting Limited, United Kingdom
    • Rajesh Thempadiyil, Dr. Reddy’s Laboratories, Ltd., India
    • Anders Vidstrup, NNIT A/S, Denmark
    • Lorrie Vuolo-Schuessler (Co-Lead), GlaxoSmithKline, USA
    • Christian Wölbeling, Werum IT Solutions GmbH, Germany
    • Charlie Wakeham (Co-Lead), Waters Corporation, Australia

  • ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation 

    • Dilip Ayyala Somayajula (Co-Lead), Boehringer Ingelheim, USA
    • Joanne Barrick, Eli Lilly & Co., USA
    • Robert Beall, PMP, (Co-Lead) ProPharma Group, USA
    • James Bergum, BergumSTATS, LLC, USA
    • Christopher C. Breen, Eli Lilly & Co., USA
    • Paul Corbishley, AstraZeneca, United Kingdom
    • Mette Kraemmer Hansen, Novo Nordisk A/S, Denmark
    • Canping Jiang, Biogen, USA
    • Line Lundsberg-Nielsen, NNE, Denmark/United Kingdom
    • Matt McMenamin, GlaxoSmithKline, USA
    • Thomas Parks, Eli Lilly & Co., USA
    • Maurice Parlane, New Wayz Consulting Ltd./CBE Pty Ltd., New Zealand
    • Pritesh Patel, Pritesh Patel Consulting, LLC, USA
    • Ajay Babu Pazhayattil, Eurofins Alphora Research Inc., Canada
    • Lori B. Pfahler, Merck & Co., Inc., USA
    • Tara Scherder, SynoloStats, USA
    • Lauren Smith, Cook Pharmica, USA
    • Thomas Stepinac, Novartis Pharma Productions GmbH, Germany
    • Kim Vukovinsky, Pfizer Inc., USA
    • Jonathan Brett Wade, Eli Lilly & Co., USA
    • Jenn Walsh, Maia Parmaceuticals, USA
    • Fred Wiles, ProPharma, Group USA

  • ISPE Good Practice Guide: Technology Transfer (Third Edition)

    • Suzanne Aldington, Lonza, United Kingdom
    • Mervin H. (Vinny) Browning III, MS, Amgen Inc., USA
    • Jose A. Caraballo, Bayer U.S., USA
    • Mike Cohen, Pfizer Inc., USA
    • Bruce Davis (Co-Lead), Global Consulting, United Kingdom
    • Beth Haas, CAI, USA
    • John Herberger (Co-Lead), Amgen Inc., USA
    • Corinne Kikegawa, Amgen Inc., USA
    • Maurice Parlane, New Wayz Consulting Ltd./CBE Pty Ltd., New Zealand
    • Ruchi Thombre, Pfizer Inc., USA
    • Noreen Troccoli, Sanofi, USA
    • Maria Vazquez-Rey, Lonza Biologics Porriño, Spain
    • Nick Vrolijk, Celldex Therapeutics Inc., USA

  • ISPE Good Practice Guide: Single-Use Technology 

    • Swapnil Ballal, Dr. Reddy’s Laboratories, India
    • Malik Belattar, France
    • Adam Goldstein, Sr., Roche/Genentech Inc., USA
    • Ekta Mahajan, Genentech Inc., USA
    • Katell Mignot-Moraux, Sartorius Stedim FMT SAS, France
    • Pietro Perrone, PhD, PE (Co-Lead), GE Healthcare, USA
    • Christopher J. Smalley, ValSource (Merck – retired), USA
    • David AR Wolton, PM Group, Ireland

  • ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts 

    • Sam Andrews, Integrity Solutions Ltd., United Kingdom
    • Erika Ballman, Albemarle Corporation, USA
    • George Bass, GGB Services, USA
    • Ivan Diamond, Bio Products Laboratory Ltd., United Kingdom
    • Robert Dillman, Eli Lilly & Co., USA
    • Sophie Zhiyao Ding, Ernst & Young LLP, USA
    • George Evgrafov, PAREXEL International, Germany
    • Kira Ford, Eli Lilly & Co., USA
    • Tami Frederick, Perrigo Company, USA
    • Elmar Harringer, CoProCo Ing.-Büro Harringer, Germany
    • Volker Hattwig, Coconeo Ltd., Germany
    • Oliver Herrmann, Q-FINITY Quality Management, Germany
    • Paul Labas, USA
    • Heather Longden, Waters Corporation, USA
    • Anthony Margetts, Factorytalk Co., Ltd., Thailand
    • Barry McManus, Empowerment Quality Engineering, United Kingdom
    • Leslie A. Paul, MS, Perrigo Company, USA
    • Siegfried Schmitt PAREXEL International, United Kingdom
    • Markus M. Schröder, Coconeo Ltd., Germany
    • Doug Shaw, Azzur Group, USA
    • Rob Stephenson, Rob Stephenson Consultancy, United Kingdom
    • Michelle Vuolo, Sanofi, USA
    • Lorrie Vuolo-Schuessler (Co-Lead), GlaxoSmithKline, USA
    • Charlie Wakeham (Co-Lead), Waters Corporation, Australia

  • ISPE Baseline® Guide: Volume 3 – Sterile Product Manufacturing Facilities (Third Edition)

    • Gordon Leichter, PhD (Lead), Belimed, Inc., USA 
    • Vincent J. Cebular, IPS, USA 
    • Jason S. Collins, AIA, IPS, USA 
    • Norman A. Goldschmidt, Genesis Engineers Inc., USA 
    • Thomas M. Huber, Skan AG, Switzerland 
    • Christa B. Myers, CRB, USA 
    • Patrick J. Poisson, United Therapeutics Corp., USA 
    • Robert L. Roy, PE, IPS, USA 
    • Matthew P. VonEsch, Exelead, USA 

  • ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data [Good eClinical Practice]

    • Jenny Gebhardt, Q-FINITY, Germany
    • Frank Henrichmann, PAREXEL International GmbH, Germany
    • Oliver Herrmann (Co-Lead), Q-FINITY, Germany
    • Angelika Kellings, Universitätsklinikum Bonn – Studienzentrale SZB, Germany
    • Marina Mangold, Esculape, Germany
    • Yvonne Rollinger, OmniComm Europe GmbH, Germany .
    • Eric J. Staib (Co-Lead), PRA Health Sciences, USA
    • Maximilian Stroebe, GSK Vaccines, Netherlands
    • Dieter Wachtmann, PAREXEL International GmbH, Germany

  • ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition)

    • David D. Dolgin, BioTechnique, USA
    • Richard Forsyth, Forsyth Pharmaceutical Consulting, USA
    • Norman A. Goldschmidt, Genesis Engineers, Inc., USA
    • Bruce D. Naumann, PhD, DABT (Co-Lead), Merck & Co., Inc., USA
    • Rizwan Sharnez, PhD, Amgen Inc., USA
    • Stephanie A. Wilkins (Co-Lead), PharmaConsult US Inc., USA

  • ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

    • Mark Foss (Co-Lead), CooperVision, United Kingdom
    • Daniel G. Franklin, CIRM, CxA, IPS, USA
    • Brett Gampper, Pfizer Global Engineering, USA
    • Nick Haycocks (Co-Lead), Amgen, Inc., USA
    • Diana K. Johnson, Elzinga Pharmaceutical Consulting Ltd., United Kingdom
    • Gary A. Knight, Commissioning Agents, Inc., USA
    • Raymond Loke, GMP Templates, Australia
    • Xavier Mol, Technord Automation, Belgium
    • Mark Andrew O’Donnell, Azzur Group LLC, USA
    • George S. Petroka, CIH, CSP, IES Engineers, USA
    • Andreas Schattschneider, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
    • Frank van der Steen, FVCS, Netherlands
    • Steven J. Wisniewski, CAI Consulting, USA

  • ISPE GAMP® Guide: Records and Data Integrity

    • Chris Clark, TenTenTen Consulting, United Kingdom
    • Colin Jones, Conformity Limited, United Kingdom
    • Tony Margetts, Factorytalk Co., Ltd., Thailand
    • Mark Newton, Eli Lilly and Company, USA
    • Arthur “Randy” Perez, Novartis (retired), USA
    • Nigel Price (Co-Lead), QCDI Ltd., United Kingdom
    • Chris Reid, Integrity Solutions Ltd., United Kingdom
    • Mike Rutherford (Co-Lead), Eli Lilly and Company, USA
    • Lorrie Vuolo-Schuessler, GlaxoSmithKline, USA
    • Charlie Wakeham, Waters Australia Pty. Ltd., Australia
    • Christopher White, Alexion Pharmaceuticals, USA
    • Guy Wingate, GlaxoSmithKline, United Kingdom
    • Sion Wyn (Co-Lead), Conformity Limited, United Kingdom

  • ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance

    • Winnie Cappucci, Bayer Healthcare (retired), USA
    • Chris Clark, TenTenTen Consulting, United Kingdom
    • Gail Evans, Technical Writer/Editor, United Kingdom
    • Colin Jones, Conformity Limited, United Kingdom
    • Randy Perez (Lead), Novartis (retired), USA
    • David Stokes, Convalido Consulting Limited, United Kingdom
    • Lorrie Vuolo-Schuessler, GlaxoSmithKline, USA
    • Christopher White, Alexion Pharmaceuticals, USA
    • Sion Wyn, Conformity Limited, United Kingdom

  • ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

    • Michael Baumstein, Pfizer, Inc., USA
    • Rod Freeman, Beckman Coulter, Inc., USA
    • Andre Gill, PE, Andre Gill Engineering, USA
    • Michelle Gonzalez, PE, Amgen, Inc. (retired), USA
    • Brian Hagopian, CPIP (Lead), Clear Water Consulting, Inc., USA
    • Jeppe Kjems, CU Engineering, Denmark
    • Joseph Manfredi, GMP Systems, Inc., USA
    • Ruby Ochoa, Trace Analytics, LLC, USA
    • Aravind Palinvelu, Roche, Singapore
    • Brian Pochini, CPIP, Sanofi, USA
    • Teri C. Soli, PhD, Soli Pharma Solutions, Inc., USA
    • Philip Sumner, PE, Pfizer, Inc., USA
    • Michael Tomaselli, Filters, Water, and Instrumentation, Inc., USA
    • Nancy Tomoney, West-Ward Pharmaceuticals, USA
    • Michael Vestermark, Novo Nordisk Biopharm, Denmark
    • Peter Vishton, Independent Consultant, USA
    • Anders Widov, Wiphe AB, Sweden

  • ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

    • Luca Arrighi, Amec Foster Wheeler, Italy
    • Denise Bender, DBender Consulting, LLC, USA
    • Mike Bradley, Amgen Inc., USA
    • Paul Daniel, Vaisala Inc., USA
    • Geoffrey Glauser, Health & Human Services, USA
    • Paul Harber, Modality Solutions, LLC, USA
    • Nick Haycocks (Lead), Amgen Inc., USA
    • Randolph Leinhauser, Merck & Co., Inc., USA
    • Elizabeth Martinez Flores, CPIP, Terra Farma SA de CV, Mexico
    • Matthew McMenamin, GlaxoSmithKline, USA
    • Derek Moss, FUJIFILM Diosynth Biotechnologies, USA
    • Mark E. Newton, Eli Lilly & Co., USA
    • Brian W. Saxton, Compliance Risk Management, USA
    • Jean Vezina, Salvus Inc., Canada
    • Christopher B. Weaver, Elanco, USA
    • Mark Zemler, FUJIFILM Diosynth Biotechnologies, USA

  • ISPE Good Practice Guide: Management of Engineering Standards

    • Jonathan Becker, RPA Engineering, USA
    • Christopher Derrett, Tintern Tech, United Kingdom
    • Jeffrey S. Fluharty (Co-Lead), Eli Lilly and Co., USA
    • Bryan W. Fluke, RPA Engineering, USA
    • Jacqueline Glanville, Abbott Laboratories, USA
    • Francesca A. McBride, Jacobs Engineering, USA
    • Duane A. Mowrey, Eli Lilly and Co., USA
    • Frank J. Smith (Co-Lead), Merck & Co., Inc., USA
    • Joseph P. Wegrzyn, Abbott Laboratories, USA

  • ISPE Good Practice Guide: Operations Management

    • Chris Abell, Pfizer Inc., USA
    • Terts Ashibi, Newleaf International Ltd., United Kingdom
    • Enric Jo Cardoso, Reig Jofre Group, Spain
    • Carrollynn Chang, USA
    • Alain Cruset, AC Consulting / ISPE France Affiliate, France
    • Jim Curry, OpStat Group, Inc., USA
    • Nick Davies, NDA Consultants, USA
    • Robert DiVasto, PE, Zavante Therapeutics Inc., USA
    • Kristin Fertig, Merck & Co., Inc., USA
    • Zeljko Granosa, Pliva Croatia Ltd., Croatia
    • Brian Guillett, NDA Consultants, USA
    • Theodore Iliopoulos, Abdi Ibrahim, Turkey
    • Wojciech Kisielnicki, Polpharma SA, Poland
    • Niranjan Kulkarni, CRB Consulting Engineers, USA
    • Jim McKiernan, McKiernan Associates, Switzerland<
    • Marzio Mercuri (Co-Lead), Polpharma Group, Poland
    • Rodney Neal, Cyberwerks, LLC, USA
    • Brian Pochini, Genzyme, USA
    • Gary Primes, PURE Bioscience, Inc., USA
    • Rey Ramos, Johnson & Johnson, Puerto Rico
    • Giuseppe Ravizzini (Co-Lead), Recordati Group, Italy
    • Carla Reed, New Creed, LLC, USA
    • Gareth Sanderson, Novartis Pharmaceuticals, France
    • Evelyn Santiago, Johnson & Johnson, Puerto Rico
    • Patricia Seymour, BioProcess Technology Consultants, Inc., USA
    • Marty Shelton, Shire Pharmaceuticals, Inc., USA
    • Dennis Stamm, InnovaNet Group, USA
    • Claus Weisemann, Luitpold Pharmaceuticals, Inc., USA
    • Glen Williams, Biotechnology Consulting, USA

  • ISPE Handbook: Sustainability

    • Robert J.E. Bowen (Co-Lead), Facilities Integration Ltd., United Kingdom
    • Dennis Begonis, BR+A Consulting Engineers, USA
    • Justin Cantor, PSC Biotech, USA
    • Robert Dream, HDR Company, LLC, USA
    • Gordon Farquharson, Critical Systems, Ltd., United Kingdom
    • Peter Gardner, Torcon, Inc., USA
    • Michelle M. Gonzalez, BioPharm Engineering Consultant, USA
    • Nicholas Haycocks (Co-Lead), Amgen Inc., USA
    • Paolo Leani, Stilmas SpA, Italy
    • Phil Sumner, Jr., Pfizer Global Engineering, USA
    • Cristina Testoni, Icos Pharma, Steelco Group, Italy
    • Josef Trapl, Takeda Pharmaceutical International GmbH, Switzerland
    • Johannes Tvrdinic, M+W Group GmbH, Germany
    • Kacy Wander, Baker Nowicki Design Studio, USA
    • Martin Wheeler, Energy & Carbon Reduction Solutions, United Kingdom
    • Ian Wilson, Schneider Electric, United Kingdom
    • Gary Zoccolante, Evoqua Water, Technologies LLC, USA

  • GAMP® Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications

    • Erik Anderson, Johnson & Johnson Family of Companies, USA
    • Chris Clark, Bard Pharmaceuticals Limited, United Kingdom
    • Niklas Bergvall, Oxford Instruments, United Kingdom
    • Winnie Cappucci, Bayer AG (retired), USA
    • Christophe DuPont, Baxter, Belgium
    • Colin Jones, Conformity Limited, United Kingdom
    • Arthur (Randy) Perez (Lead), Novartis Pharmaceuticals Corporation, USA
    • Chris Price, Aberystwyth University, United Kingdom
    • David Stokes, Venostic Solutions Group Limited, United Kingdom
    • Sion Wyn, Conformity Limited, United Kingdom

  • ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Water and Steam Systems (Second Edition)

    • Robert Augustine, Eli Lilly and Company, USA
    • Nissan Cohen (Co-Lead), Rohrback Cosasco Systems, Inc., USA
    • Diana Fischer (Co-Lead), Bausch and Lomb, USA
    • W. Roderick Freeman, Beckman Coulter Inc., USA
    • Michelle Gonzalez, Amgen Inc. (Retired), USA
    • Nick Haycocks, Amgen Inc., USA
    • Fred Lewis, Integra LifeSciences Corp., USA
    • Fred Schiller, Emergent BioSolutions, USA
    • Peter Vishton, Technology Engineer Consultant, USA
    • Anders Widov, Deltatec Pharma, Sweden
    • Steve Wisniewski, Commissioning Agents Inc., USA
    • Gary Zoccolante, Evoqua Water Technologies LLC, USA

  • ISPE Good Practice Guide: Technology Transfer (Second Edition)

    • Suzanne Aldington, Lonza, United Kingdom
    • KC Carswell, Carswell BioProcessing Consulting, USA
    • Eric Cunningham, Biogen Idec, USA
    • Bruce Davis (Co-Lead), Global Consulting, United Kingdom
    • Rich Getto (Original Co-Lead), Previously with Amgen Inc., USA
    • Daniel Gierer, Pfizer Inc., USA
    • John Herberger (Co-Lead), Amgen Inc., USA
    • Chris Hwang, Sanofi, USA
    • Phil Nethercote, GlaxoSmithKline, United Kingdom
    • Noreen Troccoli, Sanofi, USA
    • Kiren Vyas, GlaxoSmithKline, United Kingdom
    • Timothy Watson, Pfizer Inc., USA

  • ISPE Good Practice Guide: Clinical Supply Systems

    • Petra Bielmeier, F. Hoffmann-La Roche AG, Switzerland
    • Anurag Gautam, Eli Lilly & Co., USA
    • Matthew Gilson, GlaxoSmithKline, USA
    • Henryk Junker, Allergan Ltd., United Kingdom
    • Douglas Meyer, Biogen Idec, USA
    • Greg Minogue, Fisher Clinical Systems, USA
    • Eddie Montoya, Fisher Clinical Systems, USA
    • David Riege (Lead), Pfizer Inc., USA
    • Sandee Schroeder, AbbVie Inc., USA
    • Andrew Scott, Almac Clinical Services, United Kingdom
    • Jeff Young, AbbVie Inc., USA

  • ISPE Baseline® Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities (Second Edition)

    • Robert J.E. Bowen, Facilities Integration Ltd., United Kingdom
    • Manfred Brunen, PhD, Novartis Vaccines and Diagnostics GmbH, Germany
    • Norman A. Goldschmidt, Genesis Engineers, Inc., USA
    • Steven R. Miller (Co-Lead), AstraZeneca, USA
    • Marc P. Pelletier, PhD, CRB, USA
    • Dr. Scott T. Probst, Bayer Technology Services, GmbH, Germany
    • Kevin St. Onge, Zoetis, USA
    • Mark S. von Stwolinski (Co-Lead), CRB, USA
    • Wendy Zwolenski-Lambert, Novartis AG, Switzerland

  • ISPE Guide: Biopharmaceutical Process Development and Manufacturing

    • Dr. Robert Dream, PE, CPIP (Lead), HDR Company LLC, USA
    • Charles A. Clerecuzio, PE, Solutions4CO2 (US), Inc., USA
    • Sharif Disi, MECO, USA
    • Dr. Joseph Kutza, PhD, MedImmune, USA
    • Jeffery N. Odum, CPIP, IPS, USA
    • Stephan T. Orichowskyj, Hargrove Life Sciences, USA
    • Andrew C. Rayner, PM Group, Ireland
    • Gary D. Wirt, Jacobs Engineering Group Inc., USA

  • 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<br /> 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

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