2 days - Face-to-face
2000
€ H.T including breaks and lunch
Objectives of the internship
- Understand the GxP regulatory requirements for a system using artificial intelligence/machine learning technologies
- Identify the processes necessary for the implementation of your project, its validation/commissioning and its maintenance in validated condition
- Establishing the structure of the validation file
Teaching methods
- Recommendations based on GAMP5 2nd edition guidelines, Data Integrity guidelines, CSA guidance (draft) FDA CSV_for_Production_and_Quality_Systems and ISO 42001
- Exchanges with the multidisciplinary project team
Staff concerned
All persons concerned with the implementation of a system using machine learning/artificial intelligence in a GxP context: Information System Project Managers, User Project Managers, Validation Managers, Validation Managers, Quality Assurance representatives, Quality Assurance representatives, Quality Assurance representatives, Quality Assurance representatives, representatives of the Quality Assurance Department, developers...
Prerequisites : it is recommended to have a process for managing the life cycle of GxP information systems and for validating the validation systems in place.
Detailed program
Theoretical part:
Presentation of the key points methodology GAMP 5 edition 2 (Focus AI maturity model for GxP application) and the requirements of the ISO 42001 standard.
Workshop on your project:
Discussion on your project and its integration into the IT ecosystem and existing processes.
Exchange on procedures for project management, validation and maintenance in operational conditions.
=> Integrate the needs of IS with Artificial Intelligence into the existing QMS.
Identify or review the templates to document the project, its validation and its maintenance.
Establish the structure of the validation file in the case of an ML model based on text data.
The program will be adapted in advance according to your project context and your expectations.
