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Presentations
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This is a list of some presentations performed during the mentioned events:
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2015
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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
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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
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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
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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
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Cloud Computing in regulated GxP environment
- Cloud controls? What, how, how much, who?
- Compliance requirements to virtualised IT infrastructure
Concept Heidelberg, Training, Mannheim
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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
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Change management by computerized systems
- Risk-based assessment of changes
- Special cases: Patches, hot fixes, virus scanner
- Data management
Concept Heidelberg, Training, Heidelberg
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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
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Computerised System Validation conference 2015
- Data integrity: system architecture and design
Concept Heidelberg, Conference, Mannheim
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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
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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
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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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