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ONLINE COURSE

Computer System Validation in GxP Environments

Learn the basic and advanced principles of computer system validation in GxP environments.

What will you learn?

  • Understand the regulatory framework applicable to computer system validation, including 21 CFR Part 11 and EU GMP Annex 11.

  • Apply the GAMP 5 guide to system validation, understanding its categories and lifecycle.

  • Develop and manage the required validation documentation: Validation Plan, IQ, OQ, PQ, protocols, and reports.

  • Implement effective risk management to ensure data integrity and system quality.

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Computer System Validation
ONLINE
(only in Spanish)
4 hours
250€
per person
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  • Content
  • Target audience
  • Details
  • Discounts
  • Content

    In the pharmaceutical industry and other regulated sectors, validating computer systems is essential to ensure quality, safety, and regulatory compliance. This course offers comprehensive training covering regulatory foundations and the practical application of internationally recognized methodologies.

    • Regulatory environment: analysis of 21 CFR Part 11 and EU GMP Annex 11, and their application in computer system validation.
    • GAMP 5 guide: Study of system categories under GAMP 5 and their lifecycle, supporting efficient validation aligned with best practices.
    • Validation documentation: Development and management of key documents such as the Validation Plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as well as associated reports.
    • Risk management for quality: Implementation of risk-based strategies to ensure data integrity and compliance with quality standards.

  • Target audience

    • Computer system validation technicians.
    • Developers and integrators of IT systems in GxP environments.
    • Quality Assurance professionals involved in validation and compliance processes.

  • Details

    Timetable: flexible, you set the pace.
    Accessibility: available 24/7 for 30 calendar days.
    Language: Spanish

    Included materials:

    • Evaluation test.
    • PDF version of the course presentation.
    • Certificate of attendance (downloadable from the platform).

  • 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.

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