ONLINE COURSE
Maintaining Validation Status in IT Systems
Learn how to ensure validation status of IT systems in GxP environments.
What will you learn?
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Understand the key elements to ensure the validation status of IT systems in GxP environments.
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Implement effective strategies for managing changes, incidents, and configuration.
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Conduct periodic reviews and internal audits to maintain regulatory compliance.
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Clearly define the roles of Quality Assurance, Engineering, and IT in maintaining validation status.
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Tailor validation maintenance strategies based on your organization’s type and structure.
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(only in Spanish)
- Content
- Target audience
- Details
- Discounts
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Content
In regulated industries—especially pharmaceuticals and medical devices—maintaining the validation status of IT systems is critical for ensuring quality and compliance. This comprehensive course covers everything from change control to internal audits, equipping you with the tools needed to ensure the continuous validity of computerized systems.
- Ensuring validation status: principles and practices to maintain effective system validation.
- Change management: procedures for assessing and documenting changes that may impact system validation.
- Incident management: identifying, recording, and resolving issues that could affect system integrity.
- Configuration management: controlling and documenting system configurations to ensure consistency and compliance.
- Periodic review: regular evaluations to confirm systems continue to meet established requirements.
- Internal audits: planning and conducting audits to identify improvement areas and ensure regulatory compliance.
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Target audience
- Computer system validation managers and technicians
- IT professionals working in regulated GxP environments
- Engineers involved in computerized systems management
- Quality Assurance personnel overseeing IT-related processes
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Details
Timetable: flexible, you set the pace.
Accessibility: available 24/7 for 30 calendar days.
Language: SpanishIncluded materials:
- Evaluation test
- PDF copy of the training presentation
- Certificate of attendance (downloadable from the platform)
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Discounts
- 15% OFF when enrolling in more than one course.
- 15% OFF for groups from the same company.
- 15% OFF if you are a member of Catalonia.Health, Barcelona Health Hub or Madrid Health Hub.