Validation Workshop for Computer Systems
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Who Should Attend
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Description
This new and unique two day workshop is designed for the professional who has completed Computer Validation Training and/or has validation project experience.
The participants will review the FDA’s most recent Part 11 and validation guidelines and practices. Additionally, participants will have the opportunity to review several software packages on line and to actually conduct abbreviated validation project tasks.
Working in teams, the participants will have the opportunity to participate in conducting:
1. A “Gap Analysis”
2. Develop a Validation Master Plan
3. Prepare a Test Plan
4. Review and Improve a Requirements Document and Trace Matrix
5. Design Test Protocols
6. Develop a Validation Package
7. Prepare a Validation Report
This very special and intense two day workshop will help to develop new real world validation skills and to refine and enhance current tools and experiences.
The emphasis is on validation implementation and techniques. It is important that the participants have a good understanding of the principles of Computer System Validation, so that they can benefit from this interactive, participative workshop.
Participants will have the opportunity to interact with experienced peers as well as with the internationally known faculty. Teams will develop various validation deliverables and will gain invaluable validation experience and techniques.
The class work book will provide information for the development of validation tasks and as well as real sample test protocols, plans, SOPs and regulations and guidelines.