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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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2013
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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, Mannheim
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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, Mannheim
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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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Facilitating Flexible Manufacturing through Automation and IT Data Standards
joint presentation with David Stokes, Percipient Consulting Ltd
ISPE Europe, Conference, Brussels
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Pharmaceutical Quality System (PQS) - Change Management
joint presentation with Audny Stenbråten, GMP/GDP inspector, Statens legemiddelverk - Norwegian Medicines Agency, Norway
European Compliance Academy, Conference, Barcelona
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IT Infrastructure
joint presentation with Robert (Bob) McDowall, McDowall Consulting
European Compliance Academy, Conference, Barcelona
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Annex 11
Item 3 - Suppliers and Service Providers
Item 4 - Validation
in collaboration with Dr. Arno Terhechte, GMP Inspector, Bezirksregierung Münster, Germany
Concept Heidelberg, Conference, Heidelberg
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Periodic Evaluation
in collaboration with Eberhard Kwiatkowski, Bayer Healthcare, Germany
Concept Heidelberg, Conference, Heidelberg
European Compliance Academy, Conference, Barcelona
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Pharma Congress 2013 - Automation
- Benefits of structured process description according to ISA-88
Concept Heidelberg, Conference, Düsseldorf
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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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Forum Pharma 2013 - Operational Phase
- Ups and downs of the operational phase
- Annex 11 and GAMP 5 requirements: from theory to practice
- Data management
- Interface management - Supplier management
- Business continuity
- Disaster recovery
IIR Austria, Conference, Vienna
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