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

• 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, 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, Training, Copenhagen

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