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Computer Systems Validation Masterclass
16-18 June 2010
Heidelberg, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Learning Goals
As a specialist for the validation of computerised systems, this event will provide you with
- Suggestions on how the current regulatory developments have to be put into practice.
- Real-life examples of how the validation efforts can be controlled by means of risk analysis
- Answers to specific questions, like e.g. on source code review or on drawing up design specifications.
- The opportunity to bring questions from your own practice up for discussion
The event is interactive and encourages the active participation of all attendees. Lectures alternate with workshops and discussion sessions.
Background
The V model has become a worldwide standard in the validation of computerised systems. Regulatory requirements as well as industry standards, like e.g. GAMP®, are orientated towards this model. In practice, you as a validation specialist will often wonder in how far this model can be applied to your own validation projects
PROGRAMME:
- Qualification in the 21st Century
- Writing Requirements Documents
- Advanced Risk Assessment - FMEA
- Design Specification, Design Review and Risk Mitigation
- Risk Management applied to Electronic Record Controls
- Code Review
- Scaleability of Validation
- Validating Spreadsheets
- Change Control and Configuration Management
- Infrastructure Management
- Handover - the Process and Package
GAMP® is a trademark of ISPE
http://www.ispe.org/gamp5 |
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