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Presentations

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

2011

  • 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
  • Planning for success: The project "big picture"
    ISPE, Conference "Cost-effective Compliance: Practical Solutions for Computerised Systems", Brussels
  • Training in collaboration with David Stokes, Business&Decision
    - Regulatory inspections
    - Supplier and Service Provider Auditing according to Annex 11
    IIR Austria, Training, Vienna
  • Computerized System Validation according to Annex 11
    - New Annex 11 - Background and regulatory requirements
    - Implementing Annex 11 and consequences
    - Impacts of Annex 11 on the validation activities
    - Maintaining the compliance state - Periodic Evaluation
    IIR Austria, Conference, Vienna
  • Annex 11, version 2011 - Operational Phase: Items 14 - 17
    joint presentation with Klaus Eichmüller, GMP Inspector, ZAB / Regierung von Oberbayern, Germany
    Concept Heidelberg, Conference, Mannheim
  • (e)Compliant Supply Chain
    From ingredient and excipient manufacturing to patient delivery
    ISPE, Conference "Supply Chain Integration to Maximise Profit and Compliance", Frankfurt am Main
  • 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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