ISPE GAMP COP Benelux
A New Branch of the ever-growing
GAMP Tree!
Content
• Introduction
• What is a “Community of Practice”
• The birth of GAMP COP Benelux
• GAMP Community Structure
• GAMP COP Benelux
Introduction
What do you need
to grow in the world of computer
system validation?
Introduction
Current industry needs:
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Discussion with other experts
Not bound by company borders
No commercial sale-talks
Access to / Involvement in new guidance
development
• Regional aspect – limited travel (costs)
• Face to face possibilities
Introduction
The solution …..
What is a “Community of Practice”
“Group of people who share a concern,
a set of problems, or a passion about a
topic, and who deepen their knowledge
and expertise by interacting on an
ongoing basis.”
The birth of GAMP COP Benelux
• First ideas dated 2006
• Parallel initiatives in Belgium
and The Netherlands
• Further discussed during the
launch meetings of GAMP 5
(Tampa, Florida - Copenhagen)
• Start of GAMP COP Benelux
agreed in Eindhoven, NL
(19 May 2008)
GAMP Community Structure
GAMP COP Benelux
• Act as a GAMP Europe Regional COP
• Belgium
• The Netherlands
• Luxembourg
• Official Language
• English
GAMP COP Benelux
• Steering Committee
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René van Opstal – Van Opstal Consulting (NL - Chair)
Tom De Rudder – Alcon (BE – Vice-Chair)
Joost Havers – Xendo (NL – Secretary)
Tim Goossens – MSD (BE)
Frans Leijse – ITC Validation Consultants (NL)
Frans Boeijen – iValidate IT (NL)
Michel Fraipont - GSK Biologicals (BE)
Marcel Schakel – PQM Consultancy (NL)
Nico Groot – DSM (NL)
GAMP COP Benelux
Tasks of the Steering Committee:
• Maintaining contact with ISPE organisation
• Organising events with an interesting and
relevant content
• Facilitate forum discussions
• Maintain membership list, reporting,
invitations, etc.
• Communicate new developments,
publications etc.
GAMP COP Benelux
GAMP COP Benelux Charter:
• Scope
• Relationship within ISPE
– Local Affiliates
– Global GAMP organization
• Membership
• Activities
• Will be available at the website
– www.gamp-benelux.eu
GAMP COP Benelux
Events
• Face to face local GAMP COP events should take place
2-3 times per year
• Per event approximately 15 – 40 persons
• Event duration half a day to one day
• Local GAMP COP event locations and sponsorship
should rotate among the local GAMP COP members
• Each event may contain technical presentations, case
studies, workshops and round table discussions.
• A fee may be charged for workshops to cover costs.
GAMP COP Benelux
Key Past Events (1/2)
• Quality Risk Assessment + Maintaining Control in Operations 2 workshops during the ISPE Brussels congress (Apr 2009)
• Risk Assessment - Case Studies & workshops at Solvay, Weesp
(Nov 2009)
• Lean Validation - Round Table discussion at DSM, Delft (Jun
2010)
• Update of Eudralex Annex 11/ Chapter 4 - Round Table
discussions at MSD, Oss (May 2011) and Astellas, Meppel (Jun
2011)
GAMP COP Benelux
Key Past Events (2/2)
• Manufacturing Execution System - Case studies and
Round Table discussion - Alcon, Puurs (Oct 2011)
• Vendor Assessment - Workshops & Round Table
discussion at Novotek, Breda (May 2012)
• Serialisation - Round Table discussion at MSD, Oss (April
2013)
GAMP COP Benelux
• How to become a member ?
register with
• Web site www.gamp-benelux.eu
• the GAMP COP steering committee members
(See website for contact details)
• Benefit of ISPE membership
• Opt-out
GAMP COP Benelux
Some rules of engagement:
• Individual members are invited to actively
participate with ideas, knowledge, case studies,
experience, technical support, etc.
• Respecting confidentiality
• No sales talk in meetings
• Trust and openness
• Respect the other members’ view
Questions ?
Please visit our website
or
Contact your local GAMP Benelux
Steering Committte Member