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Presentations

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

2013

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

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

    Concept Heidelberg, Training, Mannheim
  • Facilitating Flexible Manufacturing through Automation and IT Data Standards
    joint presentation with David Stokes, Percipient Consulting Ltd
    ISPE Europe, Conference, Brussels
  • Pharmaceutical Quality System (PQS) - Change Management
    joint presentation with Audny Stenbråten, GMP/GDP inspector, Statens legemiddelverk - Norwegian Medicines Agency, Norway
    European Compliance Academy, Conference, Barcelona
  • IT Infrastructure
    joint presentation with Robert (Bob) McDowall, McDowall Consulting
    European Compliance Academy, Conference, Barcelona
  • Annex 11
    Item 3 - Suppliers and Service Providers
    Item 4 - Validation
    in collaboration with Dr. Arno Terhechte, GMP Inspector, Bezirksregierung Münster, Germany
    Concept Heidelberg, Conference, Heidelberg
  • Periodic Evaluation
    in collaboration with Eberhard Kwiatkowski, Bayer Healthcare, Germany
    Concept Heidelberg, Conference, Heidelberg
    European Compliance Academy, Conference, Barcelona
  • Pharma Congress 2013 - Automation
    - Benefits of structured process description according to ISA-88
    Concept Heidelberg, Conference, Düsseldorf
  • 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
  • Forum Pharma 2013 - Operational Phase
    - Ups and downs of the operational phase
    - Annex 11 and GAMP 5 requirements: from theory to practice
    - Data management
    - Interface management - Supplier management
    - Business continuity
    - Disaster recovery
    IIR Austria, Conference, Vienna

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