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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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2012
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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, Heidelberg
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PharmaKON 2012 - Good Distribution Practice (GDP) novelties 2013
- Introduction to the new European GDP Guideline
- BPD 2013 requirements case study - Measurement, control, and recording of environmental conditions
IIR Austria, Conference, Vienna
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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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BMS - Building Management Systems / FMS - Facility Management Systems
Concept Heidelberg, Conference, Cologne
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IT Infrastructure Qualification
in collaboration with Sieghard Wagner, Chemengineering, Germany
Concept Heidelberg, Conference, Cologne
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Annex 11, version 2011 - Operational Phase: Items 14 - 17
joint presentation with Audny Stenbråten, GMP/GDP inspector, Statens legemiddelverk - Norwegian Medicines Agency, Norway
European Compliance Academy, Conference, Copenhagen
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Chapitre 4, version 2011 - Documentation
joint presentation with Audny Stenbråten, GMP/GDP inspector, Statens legemiddelverk - Norwegian Medicines Agency, Norway
European Compliance Academy, Conference, Copenhagen
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A risk-based computerized system validation
in collaboration with Lydia Dolezel, Eli Lilly, Austria
- Introduction to a science-based risk management
- A risk-based approach to computerized system compliance
- Design review
- Definition of test strategy
- Change management
- Data management
- Virtualisation and cloud computing
IIR Austria, Training, 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, Formation, Heidelberg
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