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Presentations

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

2015

  • 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, Intensiv training, Barcelona
  • 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, Karlsruhe
  • Webinar Data integrity
    English version
    German version
    ECA - European Compliance Academy, Webinar
  • Data integrity: challenges and actions
    (in collaboration with Jean-Denis Mallet and Michel Raschas)
    - What data are relevant?
    - Regulatory requirements
    - MHRA Guidance on Data Integrity
    - Organisational interfaces
    - Governance
    ISPE France, Conference, Paris
  • 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, Heidelberg
  • 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, Berlin
  • Computerised System Validation conference 2015
    - Data integrity: system architecture and design
    Concept Heidelberg, Conference, Mannheim
  • Forum Pharma 2015 - Computerised System Validation: audit trail, mobile devices, e-archive
    - How efficient requirements to audit trail could be implemented
    - Audit trail reviews: identification of quality-critical process steps and reviews
    - Cloud Computing : planification of cloud-based solutions
    - Mobile applications and devices in regulatory environment: Dream or reality?
    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
  • Computer Validation
    (on behalf of David Selby)
    - Introduction to Risk Management
    - The GAMP 5 Approach

    ECA - European Compliance Academy, Intensiv training, Copenhagen

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Last update: 2017-01-01

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