Manufacturing Execution System

Case Studies & Plenary Discussions

06 Oct 2011

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

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

Alcon Belgium

Company Movie (7’)