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Presentations

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

2016

  • Data integrity
    (in collaboration with Karl-Heinz Menges and Robert (Bob) McDowall)
    - Why is data integrity important? Setting the scene
    - Principles of data integrity
    - Role of management in data integrity
    - Workshop: Analysis of an FDA warning letter
    - User account management and application configuration
    - IT support for data integrity
    - Facilitated discussion / workshop on key data integrity issues
    - Workshop: Assessing a system for data integrity
    - Supply chain integrity: organisational interfaces
    - Key learning points
    ECA - European Compliance Academy, Formation intensive, Berlin
    ECA - European Compliance Academy, Formation intensive, Barcelona
    ECA - European Compliance Academy, Formation intensive, Prag
  • Integrity of laboratory data
    (in collaboration with Arno Terhechte and Markus Zeitz)
    - What data are relevant?
    - Principles of data integrity
    - Workshop: Analysis of FDA warning letters
    - SLA and data integrity: organisational interfaces
    - Audit trails to support data integrity
    - Workshop: Elaboration of a data integrity strategy
    - The 12 tasks of data integrity
    Concept Heidelberg, Training, Mannheim
  • IT for non-IT personal
    (in collaboration with Klaus Feuerhelm and Hartmut Hensel)
    - Regulatory background
    - IT Landscape
    - Workshop : system inventory
    - Data management
    - Life cycle of computerised systems and software
    - CSV Requirements
    - IT-Trends - Opportunities / Limits / Threats
    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
  • 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, Mainnheim
  • 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, Berlin
  • Pharma IT conference 2016
    - From requirements until the qualification report: elaborating project and qualification documentation efficiently
    Concept Heidelberg, Conference, Mannheim
  • Computerised system validation 2016 - current compliance requirements for computerised systems
    - Regulatory update
    - Data integrity
    - Impact of a deficient validation of a computerised system
    - Equipment qualification supporting process validation
    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, Intensiv training, Heidelberg

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Last update: 2017-01-01

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