1 day
900
€ H.T including breaks and lunch
Objectives of the internship
- Understand and assimilate the new features of the new GAMP5 2nd edition version allowing an innovative approach to the validation of computerized and automated systems for GxP contexts.
- Update that will allow you to assimilate and apply the GAMP 5 “critical thinking” approach and the “Data Integrity” requirements in an Agile and digital transformation context in the Pharma Industry.
Teaching methods
- Course based on the ISPE guidelines, GAMP5 2nd edition, the Data Integrity guidelines, the CSA guidance (draft) FDA CSV_for_Production_and_Quality_Systems, 2025 draft of annexes 11 and 22
- Presentation and delivery of a complete course material
Staff concerned
- All persons concerned with the validation of information and automation systems (ERP, GPAO, LIMS, LIMS, ELN, SCSE, WMS, MES, PLCs...): Information System and Automation Project Managers (functional and technical), User Project Managers, User Project Managers, Validation Managers, Validation Managers, Representatives of the Quality Assurance Department, integrators, editors, hosts...
- Prerequisites: it is necessary to know the GAMP 5 first version
Detailed program
- Reminder: key points: GAMP 5 methodology
- Overview of changes in V2: what is disappearing/what is evolving/what is new
- Review of the enhancements/additions of the 2nd edition:
- “Critical thinking” approach
- IT Infrastructure Management
- Requirements specifications
- GAMP risk approach and categories
- Design review & traceability
- Testing
- Development in Agile mode
- Management of software tools
- Artificial intelligence and machine learning
- Examples/Exercises
- Validation strategy and validation deliverables in Agile mode
- Implementation of an optimized test strategy based on new FDA guidance
Upcoming dates
Paris (75)
Présentiel
Dates sur demande
Dates sur demande
Lyon (69)
Présentiel
Dates sur demande
Dates sur demande
