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CQ COP Websitewww.ispe.org/cq
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Organization of CQ COP Web Site

• About the CQ COP Web Site
• Invitation to Join
• Newsletter
• Discussion Forums
• Meetings and Events
• Publications
• CQ COP Steering Committee
• Resources
• ISPE Home

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About the CQ COP

• Mission
• The CQ COP aims to align the processes of
  commissioning and qualification with a risk- and
  science-based approach, provide input to guidance
  and other documents, and to facilitate
  understanding and organizational change necessary
  to implement this approach. This will be
  accomplished through
• Discussion and communication forums
• Education and training
• Guideline and standards review
• Facilitating links to other groups with common
  interests

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About the API COP

• Vision
• By actively providing risk based engineering, and
  science based approach, principles, inputs and
  guidance ISPEs CQ CoP be the forerunner
  community in which pharmaceutical manufacturing
  professionals can enhance their knowledge,
  capabilities and technical expertise within the
  Commissioning and Qualification processes.
• What is the Commissioning and Qualification COP?
• The Commissioning Qualification COP is a
  dynamic forum for professionals working in
  Commissioning Qualification who are seeking
  relevant and timely information to discuss and
  address issues of common interest. This newly
  developing COP is intended to provide a
  discussion and information sharing forum for
  Commissioning Qualification issues as well as a
  technical body to be associated with the newly
  developed Best Practice Guide.

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About the CQ COP

• What does the CQ COP offer members?
• The CQ COP offers
• Opportunities to become actively involved and
  help determine the focus of the CQ COP
• Training and conferences on CQ-related topics
• An electronic discussion forum to allow questions
  and answers on industry topics between COP
  members, including authors of our publications
• A newsletter communicating current activities to
  members
• Publications and articles related to
  Commissioning and Qualification

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About the CQ COP

• Upcoming CQ COP Events
• The first Commissioning and Qualification COP
  sponsored conference session will be take place
  on Tuesday, 8 November during ISPEs 2005 ISPE
  Annual meeting in Scottsdale, Arizona, USA. The
  agenda and description for the session are on the
  events page.
• Download the CQ Community of Practice
• PowerPoint Presentation

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Invitation to Join

• Join the ISPE Commissioning Qualification
  Community of
• Practice(CQ COP)
• We cordially invite you to join ISPEs
  Commissioning and Qualification Community of
  Practice (CQ COP). This newly forming ISPE
  Community of Practice is a dynamic forum for
  professionals in CQ who are seeking relevant and
  timely information to discuss and address issues
  of common interest. Members of the community have
  an unprecedented opportunity to assist in
  creating a body of knowledge specific to their
  own professional needs.
• Our Vision
• By actively providing risk based engineering, and
  science based approach, principles, inputs and
  guidance ISPEs CQ CoP be the forerunner
  community in which pharmaceutical manufacturing
  professionals can enhance their knowledge,
  capabilities and technical expertise within the
  Commissioning and Qualification processes.

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Invitation to Join

• Why Join?
• The benefits to joining the Commissioning and
  Qualification COP are numerous and include
• Membership is free to all and access to full
  benefits is available to ISPE members
• Opportunity to share knowledge and experience
  with other like-minded professionals
• Ability to positively influence the
  pharmaceutical manufacturing profession
• Offers tools to enhance productivity and keep
  current with industry trends and developments
• Convenient and efficient global networking
  opportunities

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Invitation to Join

• How to Join
• To join the CQ COP or to request additional
  information, please complete the following
  information and return it to Victoria Smoke, ISPE
  Controller by fax [phone]. You may also
  call 1-813-960-2105 or send an email
  vsmoke_at_ispe.org
• Name
• Title
• Company
• Address
• Telephone
• Email
• Area of interest related to CQ

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Newsletter

• Under Construction

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Discussion Forums

• Under Construction

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Meetings and Events

• The first Commissioning and Qualification COP
  sponsored conference session will be take place
  on Tuesday, 8 November during ISPEs 2005 ISPE
  Annual meeting in Scottsdale, Arizona, USA. The
  agenda and description for the session is as
  follows
• Description
• ISPE and the FDA have embarked on an initiative
  to significantly change procedures for
  commissioning and qualification. The initiative
  is grounded in a set of principles developed by a
  broad-based industry working group. During this
  session, sponsored by ISPEs CQ Community of
  Practice, we will engage in lively (heated?)
  discussion regarding the details of how such a
  new approach might be constructed and implemented
  based on those fundamental principles. These
  discussions will provide input to joint
  industry/regulatory efforts in the development of
  standards and guidelines that will define how
  commissioning and qualification SHOULD be
  conducted. Our goal is to save time, save money,
  and improve the quality of manufacturing
  equipment and systems.

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Meetings and Events

• Tentative Agenda
• Background and History of the CQ Initiative
• Compliance Focusing on the Important Stuff
• Process Overview
• Foundation for Focused Qualification User
  Requirements, Risk and Impact Assessments, Design
  Qualification
• Vendor Expectations and Vendor Forum
• GEP/ Commissioning vs. Qualification
• Rules of the Game Deviations and Change
  Management.
• Harmonizing with GAMP
• Application of Focused CQ to Water and Steam
  Systems Draft ISPE Good Practice Guide
• Panel Discussion

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Meetings and Events

• Conference Leader
• Mr. Robert E. Chew, PE, Vice President,
  Commissioning Agents Inc
• Speakers
• Mr. John Robert Adamson, Manager Pharma
  Compliance, Foster Wheeler Energy Ltd
• Ronald C. Branning, Vice President Global
  Quality, Genentech Inc
• Mr. Rick Gunyon, Quality Representative, Eli
  Lilly Co
• Timothy P. Howard, Team Leader, CQ, Eli Lilly
  and Co
• Mr. Alex Konopka, Engineer Consultant, Eli Lilly
  and Co
• Mr. David Petko, Engineering Director, Johnson
  Johnson
• Ulrich Rudow, VP Worldwide Eng'g Real Estate,
  Johnson Johnson
• Mr. Tulsa A. Scott, Project Manager,
  Commissioning Agents
• Sabra M. Seyer, GQTS Validation Director, Pfizer
  Inc
• Dr. Guy A. S. Wingate, Dir, Strategy, Systems
  Knowledge Mgmt, GlaxoSmithKline
• Mr. Steven J. Wisniewski, Director of Compliance,
  IPS
• Mr. Stephen K. Yu, Dir, Production Eng,
  AstraZeneca

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Publications

• Volume 4 Water and Steam Systems
• Volume 5 Commissioning and Qualification

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Publications

• Pharmaceutical Engineering Articles
• A Practical Approach to Commissioning and
  Qualification - A Symbiotic Relationship-
  Pharmaceutical Engineering Vol. 24 No. 4
  July/August 2004
• Biotech CIP Cycle Development- Pharmaceutical
  Engineering Vol. 24 No. 5 September/October 2004
• Commissioning - Key to Project Success-
  Pharmaceutical Engineering Vol 22 No 5
  September/October 2002
• Commissioning and Time-To-Market- Pharmaceutical
  Engineering Vol. 24 No. 4 July/August 2004
• Commissioning A Vital Precursor to Validation-
  Pharmaceutical Engineering Vol 14 No 4
  July/August 1994
• Communication Failure Equals Project Failure-
  Pharmaceutical Engineering Vol 20 No 5
  September/October 2000
• Customizing your CMMS System for FDA Day-to-Day
  Compliance- Pharmaceutical Engineering Vol 19 No
  3 May/June 1998

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Publications

• Designing a Standardized System Qualification
  Process- Pharmaceutical Engineering Vol 22 No 5
  September/October 2002
• Do You DQ? Design Qualification Challenges and
  Considerations- Pharmaceutical Engineering Vol.
  25 No. 2 March/April 2005
• Enhanced Design Review/Design Qualification-
  Pharmaceutical Engineering Vol 23 No 1
  January/February 2003
• Establishing Compliance of a Companys IT
  Infrastructure - A Practical Guide to Meeting GxP
  Requirements- Pharmaceutical Engineering Vol. 24
  No. 6 November/December 2004
• Facility Commissioning Basics and Engineering
  Design Documentation Requirements-
  Pharmaceutical Engineering Vol 16 No 2
  March/April 1996
• Factory Acceptance Testing (FAT) of
  Pharmaceutical Equipment- Pharmaceutical
  Engineering Vol 20 No 6 November/December 2000
• GAMP Applied to Packaged Systems "Bringing GAMP
  Down to the Factory Floor"- Pharmaceutical
  Engineering Vol 19 No 4 July/August 1999

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Publications

• Good Commissioning Practices Strategic
  Opportunities for Pharmaceutical Manufacturing-
  Pharmaceutical Engineering Vol 19 No 3 May/June
  1999
• Heightening the Success of a Project Through the
  Use of a Technical Program- Pharmaceutical
  Engineering Vol 20 No 2 March/April 2000
• Integrated Validation A Way of Streamlining
  Projects to Reduce Project Validation Time and
  Cost- Pharmaceutical Engineering Vol 18 No 1
  January/February 1998
• Making Your Process Deliver Control and
  Operability Studies Improve Process Consistency
  and Product Quality- Pharmaceutical Engineering
  Vol 20 No 3 May/June 2000
• Outsourcing Validation Results in Significant
  Cost Savings- Pharmaceutical Engineering Vol 18
  No 5 September/October 1998
• Performance Improvements An In-House CQI
  Solution to Facility Management- Pharmaceutical
  Engineering Vol 17 No 3 May/June 1997
• Practical Guide to Autoclave Validation-
  Pharmaceutical Engineering Vol 22 No 4
  July/August 2002

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Publications

• Project Programming to Start-Up- Pharmaceutical
  Engineering Vol 19 No 4 July/August 1999
• Qualification - Validation in Perspective-
  Pharmaceutical Engineering Vol 14 No 5
  September/October 1994
• Reasons, Regulations, and Rules A Guide to the
  Validation Master Plan (VMP)- Pharmaceutical
  Engineering Vol 21 No 3 May/June 2001
• Recommendations for Implementing a Calibration
  Program- Pharmaceutical Engineering Vol. 23 No.
  6 November/December 2003
• Regulatory Requirements for Computer
  Infrastructures- Pharmaceutical Engineering Vol
  23 No 3 May/June 2003
• Streamlining Validation- Pharmaceutical
  Engineering Vol 18 No 1 January/February 1998
• System Acquisition Considerations for Barrier
  Isolator Filling Lines- Pharmaceutical
  Engineering Vol 18 No 2 March/April 1998
• The Phased Approach to Pharmaceutical and Biotech
  Projects- Pharmaceutical Engineering Vol 17 No 5
  September/October 1997
• Validation and Commissioning- Pharmaceutical
  Engineering Vol 18 No 1 January/February 1998
• Validation Protocols- Pharmaceutical Engineering
  Vol 19 No 4 July/August 1999

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Steering Committee Members

• Bob Adamson Foster Wheeler Energy
• Jeff Beck Johnson and Johnson
• Bob Chew Commissioning Agents
• Scott Docherty Proctor and Gamble Pharma Inc.
• Rick Gunyon Eli Lilly Company
• Reinaldo Hernandez Day Zimmerman
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• Tim Howard Eli Lilly and CompanyScott Ludlum
  ISPE
• Gert Moelgaard NNE
• Tulsa Scott Commissioning Agents
• Luis Torres Acosta TM International
• Steve Wisniewski Integrate Project Services
  (IPS)
• Patrick Wong Bristol-Meyers Squibb

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Resources

• Pharmaceutical Glossary

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ISPE Home

• www.ispe.org