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

• Data Integrity Master Class
  (in collaboration with Karl-Heinz Menges, Arno Terhechte, Wolfgang Schumacher, and Robert (Bob) McDowall)
  - Data flow analysis
  - Workshop: Data flow analysis
  - Time synchronisation
  - QA oversight for data integrity
  - Workshop: QA oversight for data integrity
  - Cybersecurity and data integrity
  - Data governance
  - Data integrity audit results of a contract laboratory
  - Case study: data migration - Manufacturing
  - Key learning points
  ECA - European Compliance Academy, Training, Berlin
• Data integrity
  (in collaboration with Karl-Heinz Menges / Christa Färber / Arno Terhechte, 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, Copenhagen
  ECA - European Compliance Academy, Training, Budapest
  ECA - European Compliance Academy, Training, Copenhagen
  ECA - European Compliance Academy, Training, Berlin
• Raw Data
  (in collaboration with Robert (Bob) McDowall)
  - Data, Information and Knowledge
  - Interpretation of Raw Data for Production Systems
  ECA - European Compliance Academy, Training, Berlin
• Audit trail review
  (in collaboration with Robert (Bob) McDowall)
  - Audit trail vs system log
  - Requirements for the audit trails - Technical controls to aid second person review of audit trails
  ECA - European Compliance Academy, Training, Berlin
• Data integrity manager
  - Data flows
  - Data integrity and system suppliers
  - Data integrity audits
  - Role of management in data integrity
  - Data integrity training
  - Organisational interfaces and outsourcing
  Concept Heidelberg, Training, Mannheim
  Concept Heidelberg, Training, Darmstadt
• Audit Trail and Audit Trail Review
  - Purpose and objectives of audit trails (review)
  - Audit trail vs system log
  - Requirements for the audit trails: Technical controls to aid second person review of audit trails
  - Workshop: Elaborating audit trail requirements
  Concept Heidelberg, Training, Mannheim
• Integrity of laboratory data
  (in collaboration with Arno Terhechte and Markus Zeitz)
  - What data are important ?
  - 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 the data integrity
  Concept Heidelberg, Training, Karlsruhe
• IT for non-IT personal
  (in collaboration with Klaus Feuerhelm and Hartmut Hensel)
  - Hardware and software technologies
  - IT landscape within an industrial environment
  - Data management
  - Life cycle of computerised systems and software
  - CSV Requirements
  - IT-Trends - Opportunities / Limits / Threats
  Concept Heidelberg, Training, Heidelberg
• e-Compliance 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
  - Case study: requirement quality
  Concept Heidelberg, Training, Heidelberg
  Concept Heidelberg, Training, Heidelberg
• Computer Validation: Maintaining Control of Operation (MCO)
  (on behalf of David Selby, in collaboration with Robert (Rob) Stephenson and Frank Behnisch)
  ECA - European Compliance Academy, Training, Barcelona
• Cloud Computing in regulated GxP environment
  (in collaboration with Arno Terhechte and Michael Wegmann)
  - Workshop: Cloud controls? What, how, how much, who?
  - Workshop : Findings and assessments
  - Compliance requirements to virtualised IT infrastructure
  Concept Heidelberg, Training, Mannheim
• Virtualised IT systems in GMP environment: Qualification and Operation
  (in collaboration with Eberhard Kwiatkowski)
  - Introduction and definitions
  - Regulatory requirements, responsibilities, use cases
  - Planning of virtualisation projects
  - Qualification of virtualisation platform
  - Workshop : Change management
  - Life cycle, change management
  - Risk management
  - Workshop : Risk-based approach to planning of virtualisation project
  - From virtualisation to Cloud Computing
  Concept Heidelberg, Training, Mannheim
• Change management by computerised systems
  (in collaboration with Klaus Feuerhelm, Eberhard Kwiatkowski and Uwe mai)
  - Risk-based assessment of changes
  - Special cases: Patches, hot fixes, virus scanner
  - Data management
  Concept Heidelberg, Training, Mannheim
• Virtualised IT systems in GMP environment: Qualification and Operation
  (in collaboration with Robert (Bob) McDowall and Jürgen Schmitz)
  - Planning of virtualisation projects
  - Virtualisation platform: Overview
  - Planning of virtualisation platform projects
  - Workshop: Qualification documentation
  - Risk management
  - Workshop: Risk-based approach to planning of virtualisation platform
  - From virtualisation to Cloud Computing
  ECA - European Compliance Academy, Training, Copenhagen
• Pharma IT Conference 2017
  - Data Integrity findings during FDA inspections
  - Specifying Data Integrity requirements: proposal
  Concept Heidelberg, Conference, Mannheim
• Pharma Congress 2017 - Automation
  - Integrity of manufacturing data
  Concept Heidelberg, Conference, Düsseldorf
• ISPE France / GAMP® Francophone Conference 2017
  Data integrity: from theory to practice
  - Conference opening
  - Current situation and regulatory pressure
  - Data integrity begins at URS
  ISPE France, Conference, Suresnes
• 10th GAMP® 5 Conference
  - IT Infrastructure Control and Compliance
  - Global Information Systems Control and Compliance
  Concept Heidelberg, ISPE D-A-CH, APV, VDI/VDE, Conference, Mannheim
• BioMérieux Industry Spain: X Pharma Symposium
  Data integrity for the pharmaceutical microbiology laboratory
  - Introduction to Data Integrity
  - User account management and application configuration
  - Data integrity and audit trails
  - Analysis of FDA warning letters: Laboratory weaknesses
  - Key learning points: The twelve data integrity tasks
  BioMérieux Industry Spain
  - User conference, Madrid
  - User conference, Barcelona

Information