Committee Directory

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International

Change Management Steering Team

  • Role: The Change Management Steering Team is responsible for providing oversight and ensuring integration of ISPE‟s major change initiatives in 2012. This includes both trouble-shooting functional integration issues and serving as the main point of coordination for communication regarding the changes throughout the Society.
    Chair: Charlotte Enghave Fruergaard, NNE Pharmaplan
    Board Liaison: Brian Lange
    Staff Project Manager: Karleen Kos

Content Evaluation Team

  • Role: Solicit and evaluate proposals for appropriate content, and recommend appropriate Continuing Education formats (i.e., conferences, training, publications, and on-line learning).
    Chair: Kate McCormick
    Co-Chair: Allan Pfitzenmaier, VecTech Pharma
    Board Liaison: Tim Howard
    Staff Project Manager: Kate McCormick

Facility of the Year Committee (FOYC)

  • Role: Establish the Facility of the Year Awards program as the most widely acknowledged and premier global awards program recognizing state-of-the-art pharmaceutical manufacturing projects utilizing innovation and technology to reduce the cost of producing high quality medicines.
    Chair: Jim Kimmel, Cephalon
    Board Liaison: Gordon Leichter
    Staff Project Manager: Scott Ludlum

Future Visioning Team (FVT)

  • Role:To identify where the industry is headed over the next five years, enabling ISPE to develop needed products and services to prepare Members for industry transitions while properly utilizing ISPE resources to assist the industry and its regulatory authorities. The FVT will make recommendations to the International Board of Directors to direct Society business and align functions and activities.
    Chair: VP of Knowledge Management, Victoria Smoke, Karleen Kos
    Co-Chair: Brian Lange, Merck
    Co-Chair: Bob Chew, Commissioning Agents Inc
    Board Liaison: Gordon Leichter
    Staff Project Manager: VP of Knowledge Management, Victoria Smoke, Karleen Kos

Guidance Documents Committee

  • Role: Oversee the development of all Society guidance for Industry, utilizing personnel from industry, regulators, and suppliers.
    Chair: Nick Haycocks, Amgen
    Co-Chair: Chris Derrett, Merck
    Board Liaison: Guy Wingate
    Staff Project Manager: Gloria Hall

International Board of Directors

  • Role: Create the Society's vision, establish its basic goals and policies, approve its financial direction and provide guidance to the Committees, Councils, Task Teams, COP Steering Committees and Professional Staff.
    Chair: Randy Perez, Novartis
    Board Liaison: Randy Perez
    Staff Project Manager: Nancy S. Berg, Victoria Smoke, Karleen Kos

Executive Council

  • Role: Provide strategic leadership for the Society, review operational issues for presentation to the International Board of Directors in summary form and act on behalf of the Board between meetings.
    Chair: Randy Perez, Novartis
    Board Liaison: Randy Perez
    Staff Project Manager: Nancy S. Berg, Victoria Smoke, Karleen Kos

Finance and Audit Committee

  • Chair: Damian Greene, Pfizer
    Board Liaison: Damian Greene
    Staff Project Manager: Victoria Smoke

International Leadership Forum (ILF)

  • Mission: To provide an opportunity for thought leaders in the Pharmaceutical Industry to identify and influence direction and align the industry globally, establish dialogue with regulators to discuss critical technological issues, identify opportunities for innovation, promote consistency, and seek worldwide harmonization where appropriate.
    Chair: Tim Tyson, Aptuit Inc
    Board Liaison: Udo Vetter
    Staff Project Manager: Nancy S. Berg, Bryan Wright

“ISPE University” Committee

  • Role: To establish and maintain a curriculum that will be the centerpiece of a Professional Development Program (PDP) for Members of the Society and other pharmaceutical professionals to expand their skills and knowledge, enabling them to grow both personally and professionally, yielding significant benefits to them and their employer.
    Chair: Tim Howard, Commissioning Agents Inc
    Co-Chair: Bill Deckert, Alliance Engineering Inc
    Co-Chair: Cheryl Tucker, Eli Lilly
    Board Liaison: Tim Howard
    Staff Project Manager: VP of Knowledge Management

ISPE University Website Subcommittee

  • Chair: Winnie Cappucci, Bayer Healthcare (retired)
    Co-Chair: Chris Muratore
    Co-Chair: Ali Montes
    Board Liaison: Randy Perez
    Staff Project Manager: Carol Winfield

Marketing Advisory Council (MAC)

  • Role: Assist ISPE leadership in guiding future marketing related activities such as messaging, targeting, and related strategic initiatives so that ISPE may deliver “Member-focused” products and services of greatest need to Members worldwide.
    Chair: Andy Signore, IPS
    Board Liaison: Jim Breen
    Staff Project Manager: Karleen Kos

Membership Development Committee (MDC)

  • Role: Working with and through Staff and other Society volunteer groups, engage in activities that support recruitment and retention of core members as described in ISPE‟s Strategic Plan. To this end, recommend enhancements to membership benefits, services, and programs for which a business case can be made. Develop programs to improve Member engagement and volunteerism. Analyze membership development opportunities and provide Staff with industry knowledge and insight for tactical implementation.
    Chair: Alan Jones, Duke Energy
    Co-Chair: Karleen Kos
    Board Liaison: Andy Skibo
    Staff Project Manager: Rosemary Jones

MDC Recruitment and Retention Subcommittee

  • Chair: John Holton, Cephalon
    Co-Chair: Michelle Gonzalez, BioPharm Engineering Consultant
    Board Liaison: Andy Skibo
    Staff Project Manager: Rosemary Jones

MDC Volunteer Development Subcommittee

  • Chair: Jane Brown, GSK
    Co-Chair: Scott Ludlum
    Board Liaison: Andy Skibo
    Staff Project Manager: Scott Ludlum

Nominating Committee

  • Role: Select the best-qualified representatives from among the full, active international membership to serve as candidates for the International Board of Directors.
  • Chair: Randy Perez, Novartis
    Staff Project Manager: Nancy S. Berg, Karleen Kos

Pharmaceutical Engineering Committee (PEC)

  • Role: Identify topics of current interest, seek author leads and information sources to enhance content of magazine, Web site, E-letters, and other communication media.
    Chair: Jeff Hargroves, ProPharma Group
    Co-Chair: Judy Samardelis, QIAGEN
    Board Liaison: Charlotte Enghave Fruergaard
    Staff Project Manager: Gloria Hall

Professional Certification Commisssion

  • Role: Develop and administer valid, reliable, and defensible credential programs approved by the ISPE Board of Directors.
    Chair: Ken Ewan, MedImmune
    Co-Chair: Chuck Stock, IPS
    Co-Chair: Robert Lechich, Pfizer
    Board Liaison: Andre Walker
    Staff Project Manager: Michael Phelan

PCC Appeals Committee

  • Chair: David Fawcett, Pharmaceutical Engineering Consultants
    Board Liaison: Andre Walker
    Staff Project Manager: Michael Phelan

PCC Eligibility Committee

  • Chair: William J “Joe” Robinson, Commissioning Agents Inc
    Board Liaison: Andre Walker
    Staff Project Manager: Michael Phelan

PCC Exam Development Committee

  • Chair: Michael Ruff, Metrics Inc
    Co-Chair: Damian Gerstner, Boehringer Ingelheim Vetmedica Inc
    Board Liaison: Andre Walker
    Staff Project Manager: Michael Phelan

PCC Recertification Committee

  • Chair: Ron Massey, Pfizer
    Board Liaison: Andre Walker
    Staff Project Manager: Michael Phelan

Quality Assurance/Library Committee

  • Role: The Quality Assurance/Library Committee will become a subgroup of the “ISPE University” Committee in 2012 and remain so until a mission and role is developed for them. As an “ISPE University Committee” subgroup, they will advise on matters related to organizing, reviewing, and maintaining ISPE‟s body of knowledge in a manner most likely to support the goals of “ISPE University.”

Regulatory and Compliance Committee

  • Role: Help develop and/or influence the understanding and implementation of critical regulatory elements, using science and risk-based processes through partnership with Regulatory Authorities. Serve as the coordinator of Regulatory Authority relations for all Society groups.
    Chair: Director of Regulatory Affairs
    Co-Chair: Chuck Hoiberg, Pfizer
    Board Liaison: Joe Famulare
    Staff Project Manager: Director of Regulatory Affairs

Web Reorganization Working Group

  • Chair: Phil Pursifull, Commissioning Agents Inc
    Board Liaison: Damian Greene
    Staff Project Manager: Carol Winfield

Young Professionals Committee

  • Role: Foster programs to attract students, young professionals and new professionals entering the industry to become active participants in the Society and to utilize ISPE as their primary resource for career and continuing professional development.
    Chair: Daniel Ramsey, Commissioning Agents Inc
    Co-Chair: Amy Lineberry, SpecLine Consulting
    Co-Chair: Emily Stump, Commissioning Agents
    Board Liaison: Stephen Tyler
    Staff Project Manager: Rosemary Jones, Tracey Ryan

Communities of Practice

COP Council (COPC)

  • Role: To provide oversight and strategic leadership in the development and growth of ISPE Communities of Practice.
    Chair: Mike Arnold, Pfizer
    Co-Chair: Paige Kane, Pfizer
    Board Liaison: Damian Greene
    Staff Project Manager: Scott Ludlum

API

  • Chair: Rick McCabe, Pfizer
    Co-Chair: Patrick Wong, IPS
    Board Liaison: Brian Lange
    Staff Project Manager: Susan Obarski

Biotechnology

  • Chair: Wendy Zwolenski-Lambert, Abbott
    Co-Chair: Nathan McKnight, Genentech
    Board Liaison: Andre Walker
    Staff Project Manager: Scott Ludlum

C&Q

  • Chair: Rose Mary Dollard, Johnson and Johnson
    Co-Chair: Frank Van Der Steen, SynCo Bio Partners B.V.
    Board Liaison: Tim Howard
    Staff Project Manager: Susan Obarski

Containment

  • Chair: Beth Brock, Eli Lilly & Co
    Co-Chair: Alan George, ILC Dover Inc
    Board Liaison: Morten Stenkilde
    Staff Project Manager: Susan Obarski

Critical Utilities

  • Chair: Joseph Manfredi, GMP Systems Inc
    Co-Chair: William J “Joe” Robinson, Commissioning Agents Inc
    Board Liaison: Jim Breen
    Staff Project Manager: Susan Obarski

Disposables

  • Chair: Adam Goldstein, Genentech
    Co-Chair: Wayne Flaherty, Compliance Concepts International
    Board Liaison: Udo Vetter
    Staff Project Manager: Susan Obarski

Engineering Standards Benchmarking

  • Chair: Frank Smith, Merck
    Co-Chair: Francesca McBride, Jacobs Engineering
    Board Liaison: Gordon Leichter
    Staff Project Manager: Cicelle Domingo

GAMP

  • Chair: Winnie Cappucci, Bayer Healthcare (retired)
    Co-Chair: Kevin Martin, Azzur Group Ltd
    Co-Chair: Christopher Reid, Integrity Solutions
    Board Liaison: Guy Wingate
    Staff Project Manager: Scott Ludlum

Good Control Laboratories Practices

  • Chair: Kapil Bhargava, Former Regulatory Official, CDSCO
    Co-Chair: Jawahir Sipahimalani, Chem-Med Analytical Laboratories
    Board Liaison: Udo Vetter
    Staff Project Manager: Cicelle Domingo

HVAC

  • Chair: Norm Goldschmidt, Genesis Engineers
    Co-Chair: Nick Haycocks, Amgen
    Board Liaison: Stephen Tyler
    Staff Project Manager: Susan Obarski

Investigational Products

  • Chair: Steven Yoder, Eli Lilly Inc
    Co-Chair: Esther Sadler-Williams, Aptuit Ltd
    Board Liaison: Doyle Johnson
    Staff Project Manager: Susan Obarski

Operations Management

  • Chair: Gary Primes, PURE Bioscience
    Co-Chair: Nick Davies, NDA Consultants
    Board Liaison: Jim Breen
    Staff Project Manager: Cicelle Domingo

Oral Solid Dosage

  • Chair: Bob Matje, Pfizer
    Co-Chair: Dave DiProspero, Stantec Consulting
    Board Liaison: Damian Greene
    Staff Project Manager: Susan Obarski

Packaging

  • Chair: Mel Bahr, MGS Machine Corporation
    Co-Chair: Randy Leinhauser, Pfizer
    Board Liaison: Brian Lange
    Staff Project Manager: Susan Obarski

PQLI® Management Team

  • Role: ISPE will act as integrator for all pharmaceutical disciplines to assist Industry and Regulators in advancing manufacturing sciences in order to achieve excellence in drug development and in pharmaceutical production. Manufacturing Sciences shall be defined as the integrated application of scientific knowledge, technical innovation and quality risk management to deliver product and process understanding.
    Chair: Joe Famulare, Genentech Inc
    Co-Chair: Stephen Tyler, Abbott Laboratories
    Board Liaison: Joe Famulare
    Staff Project Manager: Scott Ludlum

PQLI® Technical Committee

  • Chair: Stephen Tyler, Abbott Laboratories
    Co-Chair: Chris Potter, CMC Pharmaceutical Consultant
    Board Liaison: Stephen Tyler
    Staff Project Manager: Gloria Hall

Process Analytical Technology

  • Chair: Kevin Klopfer, Celgene Corp
    Co-Chair: Eric Unrau, CRB Consulting Engineers
    Board Liaison: Joe Famulare
    Staff Project Manager: Susan Obarski

Process/Product Development

  • Chair: Avril Vermunt, Amgen
    Co-Chair: Robert Piperno, GSK
    Board Liaison: Guy Wingate
    Staff Project Manager: Susan Obarski

Project Management

  • Chair: Keith Gibbs, Yonkers Industries
    Co-Chair: John Postiglioni, Spirax Sarco Inc
    Co-Chair: Alf Penfold, Pfizer
    Board Liaison: Charlotte Enghave Fruergaard
    Staff Project Manager: Cicelle Domingo

Sterile Products Processing

  • Chair: Robert Roy, IPS
    Co-Chair: Thomas Huber, Skan AG
    Co-Chair: Thomas Ofsharick, GSK
    Board Liaison: Andy Skibo
    Staff Project Manager: Susan Obarski

Sustainable Facilities

  • Chair: Paul Malinowski, Becton Dickinson and Co
    Co-Chair: Haydn Pike, Norgine Ltd
    Board Liaison: Morten Stenkilde
    Staff Project Manager: Susan Obarski

Affiliates and Chapters

Affiliate/Chapter Boards of Directors/Management Committees

  • Role: Manage operations of national/regional Affiliates/Chapters in a cost-efficient manner, consistent with the standards of the International, providing programs of particular interest to Members in that country or region. Interface effectively within the larger Society to ensure integration between local strategies and operations and those of ISPE as a whole.

Asia Pacific Affiliate Council (APAC)

  • Role: Recommend policies and procedures to the International Board of Directors that will improve services to Members in the region. Interface effectively within the larger Society to ensure integration between local strategies and operations and those of ISPE as a whole.
    Chair: Tatsuro Miyagawa, CMIC CMO CO., LTD.
    Board Liaison: Morten Stenkilde
    Staff Project Manager: Chester Chu, Rhonda Ng

Europe Affiliate Council (EAC)

  • Role: Recommend policies and procedures to the International Board of Directors that will improve services to Members in the region. Interface effectively within the larger Society to ensure integration between local strategies and operations and those of ISPE as a whole.
    Chair: Bob Adamson, RBQ Services Limited
    Co-Chair: Jean Francois Duliere, Technip France
    Board Liaison: Charlotte Enghave Fruergaard
    Staff Project Manager: Elmarie Herloff-Petersen

North America South America Affiliate Council

  • Role: Recommend policies and procedures to the International Board of Directors that will improve services to Members in the region. Interface effectively within the larger Society to ensure integration between local strategies and operations and those of ISPE as a whole.
    Chair: Mark Mathis, Integrated Process Technology Inc
    Co-Chair: Corey Veverka, Total Validation Services Inc
    Board Liaison: Doyle Johnson
    Staff Project Manager: Karleen Kos, Tracey Ryan

For Committee Chair contact information, please consult the ISPE Membership Directory


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