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GAMP Francophone

Upcoming events

Next Round Tables of GAMP Francophone at Hotel Ibis Orly South on:

  • 8 March 2017: Archiving
  • 19 October 2017: IT infrastructure compliance (to be confirmed)

The Round Table topics could change depending of the GxP current situation. If you wish to be informed regularly about the activties of GAMP Francophone, you should send an e-mail with your contact data to: gamp[dot]fr[at]kereon[dot]ch

History and objectives

GAMP Francophone, which is the French speaking entity of the international GAMP Community - GAMP Community of Practice - has been founded on request of ISPE France on June 15th 2006, by Michel Raschas (PROGMP) and Yves Samson (Kereon AG), where the both are board members of ISPE French affiliate.

GAMP Francophone comes fully within the context of the approach initiated by the GAMP Forum in 1991 in UK ; i.e.:

  • To offer a discussion and experience sharing plateform for the pharmaceutical industry, its suppliers and service providers, and for the regulators as well
  • To elaborate, as appropriate, articles, recommendations, guides about the regulatory compliance of computerized systems
  • To support the pharmaceutical industry and its suppliers by the definition of efficient and commensurate compliance approaches in order to ensure the achievement of applicable regulatory requirements for automated and IT systems.

LinkedIn

You can join the group GAMP Francophone (ISPE) on LinkedIn Image not found.

Past events

Since 2006, the following topics have been discussed during GAMP Francophone events:

  • 2016-10-27
    Audit-trails and their review
  • 2016-04-21
    Mobile applications
  • 2015-10-08
    Disaster Recovery and Business Continuity Planing
  • 2015-02-05
    Compliant Agility
  • 2014-10-09
    Design ReviewS
  • 2014-02-06
    IT Infrastructure Qualification
  • 2013-10-03
    Data Integrity
  • 2013-03-28
    GAMP Good Practice Guide : A Risk-Based Approach to Testing of GxP Systems (second edition)
  • 2012-10-11
    Platform and environment Qualification
  • 2012-06-20
    Configuration and parametrisation
  • 2012-02-01
    Outsourcing and SLA (Service Level Agreement)
  • 2011-10-13
    Virtualisation of IT infrastructure: virtualisation, cloud, ...
  • 2011-06-16
    Revised Annex 11 (Part 2)
  • 2011-02-01
    Revised Annex 11 (Part 1)
  • 2010-10-14
    Impact of the GAMP software categories on the compliance activities
  • 2010-06-16
    Elaborating URS and FS
  • 2010-03-11
    Risk management
  • 2008-10-09
    European GMP: draft of Annex 11 and Chapter 4, which challenges?
  • 2008-01-24
    GAMP® Good Practice Guide Testing of GxP systems", Version 2005
  • 2007-10-11
    Inspection readyness for global IT systems
  • 2007-10-11
    Inspection readyness for local systems
  • 2007-02-01
    GAMP® 4 - Appendices M6, M10 and SLA (Service Level Agreement)
  • 2006-10-03
    Customer-supplier relationship and SLA (Service Level Agreement)

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Last update: 2017-01-01

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