ONLINE COURSE
Periodic Review of IT Systems Course
Learn how to conduct periodic reviews of IT systems in accordance with GAMP 5.
What will you learn?
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Understand the principles of periodic review of IT systems according to GAMP 5.
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Establish scheduling and determine appropriate review frequency.
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Prepare effective checklists for system evaluation.
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Identify key stages and assign responsibilities during the review process.
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Develop action and remediation plans following periodic reviews.
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Apply acquired knowledge through practical examples.
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(only in Spanish)
- Content
- Target audience
- Details
- Discounts
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Content
In regulated environments, periodic review of IT systems is essential to ensure ongoing compliance and optimal performance. This course provides detailed training on how to carry out these reviews following GAMP 5 guidelines, from planning through corrective actions implementation.
- Introduction to Periodic Review according to GAMP 5: importance and objectives of periodic reviews in IT systems.
- Scheduling and frequency: criteria for determining periodicity based on risk management.
- Preparation for the review:
- Development of checklists adapted to system characteristics.
- Collection and analysis of relevant documentation.
- Execution of the review:
- Phases of the review process.
- Assignment of roles and responsibilities.
- Effective communication between involved teams.
- Post-review:
- Creation of action plans to address deviations or improvement areas.
- Implementation of remediation plans and follow-up on corrective actions.
- Practical case: application of learned concepts in a realistic scenario to reinforce knowledge.
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Target audience
- IT system validation managers and technicians
- IT system developers in GxP environments
- Quality assurance managers and technicians
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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 version 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.