EU GMP Annex 11: A Complete Overview of Computerised Systems
About Course
This essential online course provides a comprehensive foundation in EU GMP Annex 11, the cornerstone regulatory guidance for computerised systems in the pharmaceutical and healthcare industries.
This course is designed for professionals in IT, Quality Assurance, Validation, and Operations.
What You Will Learn:
- The core requirements of EU GMP Annex 11
- Implementing a risk-based approach to system validation
- Ensuring data back-up and archiving
- Managing electronic signatures and audit trails
- Oversight of suppliers and third-party services
Who Should Enroll:
- IT Professionals
- Validation Professionals
- QA Professionals
- Operational Executives
Course Format:
- Self-paced online modules
- Lifetime access
- Quizzes & certification upon completion
Course Content
Module I
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Introduction to EU GMP Annex 11
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Principles of EU GMP Annex 11
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Quality System and Risk Management
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System Requirements
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Pre Assessment-1
Module II
Module III
Others
Final Assessment
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Student Ratings & Reviews
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