1 day
680
€ H.T including breaks and lunch
Objectives of the internship
- Understand and assimilate the process of maintaining the GxP validated state of computerized and automated systems according to the GAMP5 approach
- Assimilate and apply the modular approach of GAMP 5 and the new requirements related to “Data Integrity”
- Assimilate and apply the “Risk Analysis” approach to comply with 21CFR part 11, Annex 11, and the new Data Integrity guidelines
- Know how to define the activities and the necessary effort to maintain the validated state of each computerized system by assimilating a “modular” approach: exchange management, periodic reviews...
Teaching methods
- Course based on GAMP 5 methodology and Data Integrity requirements
- Concrete case studies
- Work in sub-groups
- Exposed
Staff concerned
All persons concerned with the validation of information and automation systems (ERP, GPAO, LIMS, LIMS, SCSE, WMS, SCC, MES, PLCs...): Information System and Automation Project Managers (functional and technical), User Project Managers, User Project Managers, Validation Managers, Quality Assurance Department representatives...
Detailed program
1 — REMINDER OF THE REGULATORY REQUIREMENTS FOR MAINTAINING A VALID STATE
2 — PRINCIPLES OF MAINTAINING THE VALIDATED STATE
- Key points
- Positioning validated state maintenance in the system validation life cycle
- Description of a complete maintenance process
- Activities and documents relating to the maintenance of validated systems: periodic reviews, subcontracting, subcontracting, security and access, change control, archiving of records, backup and restoration of systems, operational continuity
- Focus on “Change control”
3 — IMPLEMENTATION OF THE “OPERATIONS” PHASE
- Definition of the applicable scope: infrastructure, software, applications, data
- Definition of the organization, responsibilities, and necessary activities
- Development of the documents, procedures and records necessary for the various activities of the maintenance process: periodic reviews, subcontracting, security and access, change control, archiving of records, backup and restoration of systems, operational continuity.
4 — PRACTICAL EXERCISES
- Exercises to set up a maintenance process
- Exercises in writing “change control” procedures, system backup/restore, periodic review, “service charter” for subcontracting.
