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Presentations

This is a list of some presentations performed during the mentioned events:

2012

  • Cloud Computing in regulated GxP environment
    - Cloud controls? What, how, how much, who?
    - Compliance requirements to virtualised IT infrastructure

    Concept Heidelberg, Training, Heidelberg
  • PharmaKON 2012 - Good Distribution Practice (GDP) novelties 2013
    - Introduction to the new European GDP Guideline
    - BPD 2013 requirements case study - Measurement, control, and recording of environmental conditions
    IIR Austria, Conference, Vienna
  • Virtualised IT systems in GMP environment: Qualification and Operation
    - Management of virtualisation project
    - Case study: virtualisation - design and documentation
    - Risk management
    - From virtualisation to cloud computing

    Concept Heidelberg, Training, Heidelberg
  • Change management by computerized systems
    - Risk-based assessment of changes
    - Special cases : Patches, hot fixes, virus scanner
    - Data management

    Concept Heidelberg, Training, Heidelberg
  • BMS - Building Management Systems / FMS - Facility Management Systems
    Concept Heidelberg, Conference, Cologne
  • IT Infrastructure Qualification
    in collaboration with Sieghard Wagner, Chemengineering, Germany
    Concept Heidelberg, Conference, Cologne
  • Annex 11, version 2011 - Operational Phase: Items 14 - 17
    joint presentation with Audny Stenbråten, GMP/GDP inspector, Statens legemiddelverk - Norwegian Medicines Agency, Norway
    European Compliance Academy, Conference, Copenhagen
  • Chapitre 4, version 2011 - Documentation
    joint presentation with Audny Stenbråten, GMP/GDP inspector, Statens legemiddelverk - Norwegian Medicines Agency, Norway
    European Compliance Academy, Conference, Copenhagen
  • A risk-based computerized system validation
    in collaboration with Lydia Dolezel, Eli Lilly, Austria
    - Introduction to a science-based risk management
    - A risk-based approach to computerized system compliance
    - Design review
    - Definition of test strategy
    - Change management
    - Data management
    - Virtualisation and cloud computing
    IIR Austria, Training, Vienna
  • eCompliance Manager training
    - CSV life cycle
    - System classification according to the GAMP software categories
    - Requirements, specifications, and life cycle
    - Guidelines for preparing specifications
    - Needs and requirements capture
    - Elaboration process for requirement and specification
    Concept Heidelberg, Formation, Heidelberg

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Last update: 2016-08-12

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