manufacturing execution system - gamp benelux introduction... · o6-oct-2011 manufacturing...
TRANSCRIPT
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Manufacturing Execution System
Case Studies & Plenary Discussions
06 Oct 2011
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Welcome & Introduction
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Agenda
14.00 – 14.30 Welcome & Introduction
• Introduction ISPE GAMP COP Benelux (Tim Goossens)
• Introduction ALCON Belgium (Tom De Rudder)
14.30 – 15.40 Presentation with Q&A
• MES - GAMP5 & ISA-95 standards (René van Opstal)
15.40 – 16.00 Coffee/Tea break
16.00 – 16.45 Case Study with Q&A
• MES implementation at Alcon (Mikaël Couvreur, Alcon)
16.45 – 17.45 MES - Round Table Discussion (All)
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Agenda
17.45 – 18.30 Dinner – kindly sponsored by Alcon
18.30 – 19.15 Presentation with Q&A
• Electronic Batch Records (Mathijs Jansen, Astellas NL)
19.15 - 20.00 MES - Round Table Discussion (All)
20.00 Wrap-up & Close
• Reflection on expectation
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Introduction
The rules of engagement:
• This meeting may contain technical presentations, case studies and discussions.
• Individual members are invited to actively participate with ideas, knowledge, case studies, experience, technical support, etc.
• Respecting confidentiality
• No sales talk in meetings
• Trust & openness
• Respect the other members’ view
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Introduction (Cont’d)
Who do we have in the room?
Please present yourself shortly:
• Name, Company & Role
• What do you expect of today’s meeting?
Housekeeping • Emergency exits
• Toilets
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ISPE GAMP COP Benelux
The youngest branch of the ever-growing GAMP Tree!
Tim Goossens – MSD
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The ‘Why?’
What do you need
to grow in the world of computer
system validation?
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The ‘Why?’
Current industry needs:
• 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
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The ‘Why?’
The solution …..
COP = 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.
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GAMP COP Benelux
• Formal start as joined Be-Nl initiative in May 2008,
with preparations in both countries as of 2006
• Strong relationship within ISPE • Through local affiliates
• As part of the Global GAMP organization
• Regional coverage • Belgium
• The Netherlands
• Luxembourg (no members yet …)
• Official Language • English
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GAMP COP Benelux
Steering Committee • Tim Goossens – MSD (BE - co-Chair)
• René van Opstal – Van Opstal Consulting (NL - co-Chair)
• Frans Leijse – ITC Validation Consultants (NL - Secretary)
• Frans Boeijen – iValidate IT (NL)
• Tom De Rudder – Alcon (BE)
• Danny Van Hemelen - GSK Biologicals (BE)
• Nico Groot – DSM (NL)
• Betty Jansen - Blom – Solvay Pharmaceuticals (NL)
Sponsors • Joop Hoving – DSM (ISPE Dutch affiliate)
• Yves Buelens – Catalent Pharma Solutions (ISPE Belgium affiliate)
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www.GAMP-Benelux.eu
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Key Past Events
• 2 workshops during the ISPE Brussels congress (Apr 2009) • “Quality Risk Assessment”
• “Maintaining Control in Operations”
• Case studies & workshops at Solvay, Weesp (Nov 2009) • “Risk Assessment”
• Round table discussion at DSM, Delft (Jun 2010) • “Lean Validation”
• Round table discussions at both MSD Oss (May 2011) and Astellas, Meppel (Jun 2011) • “Update of Eudralex Annex 11/ Chapter 4”
+ ongoing support of ISPE congresses in Brussels
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How to become a member
• GAMP Benelux COP
• register with
• Web site www.gamp-benelux.eu
• the GAMP COP steering committee members
(See website for contact details)
• COP Membership is free of charge
• No ISPE membership required, but preferred
• Opt-out
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Alcon Belgium
Company Movie (7’)