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
- 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
