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Presentations

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

2014

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

    Concept Heidelberg, Training, Mannheim
  • 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
  • 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

    ECA - European Compliance Academy, Training, Prag
  • Data integrity: how important are my data?
    Concept Heidelberg, Conference, Mannheim
  • Forum Pharma 2014 - Annex 11 : First experiences
    - Ensuring data integrity
    - Efficient computerised system validation based on successful risk management
    - Data integrity workshop: Maintaining control in operation
    - Data integrity and SLA
    IIR Austria, Conference, 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, Training, Heidelberg

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