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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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2011
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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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Planning for success: The project "big picture"
ISPE, Conference "Cost-effective Compliance: Practical Solutions for Computerised Systems", Brussels
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Training
in collaboration with David Stokes, Business&Decision
- Regulatory inspections
- Supplier and Service Provider Auditing according to Annex 11
IIR Austria, Training, Vienna
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Computerized System Validation according to Annex 11
- New Annex 11 - Background and regulatory requirements
- Implementing Annex 11 and consequences
- Impacts of Annex 11 on the validation activities
- Maintaining the compliance state - Periodic Evaluation
IIR Austria, Conference, Vienna
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Annex 11, version 2011 - Operational Phase: Items 14 - 17
joint presentation with Klaus Eichmüller, GMP Inspector, ZAB / Regierung von Oberbayern, Germany
Concept Heidelberg, Conference, Mannheim
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(e)Compliant Supply Chain
From ingredient and excipient manufacturing to patient delivery
ISPE, Conference "Supply Chain Integration to Maximise Profit and Compliance", Frankfurt am Main
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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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