Anne-Sophie Citti is a validation consultant engineer working at the CVO-EUROPE’s Geneva office since 2017. She is now in charge of computerized system validation and process validation in medical devices companies.
Read the description of her last mission:
I’m currently working for a medical devices company which develops, manufactures and distributes innovative medical devices for sports medicine and tissues reconstruction. In the scope of a new product introduction, my task was to perform the sealing validation of a flexible peel pouch. The validation of packaging process shall be performed as per ISO 11607 – Packaging for terminally sterilized medical devices.
The process validation was performed to ensure compliance to all internal and regulatory requirements. First, an Operational Qualification was conducted to challenge the critical process parameters within worst cases conditions (low and high). This execution ensured that the equipment will produce products that meet all defined requirements under all anticipated conditions of manufacturing. Then, a Performance Qualification was conducted demonstrating the process will consistently produce acceptable products under specified operating conditions. PQ execution demonstrates through statistical analysis that the process in under control and capable. The output of the performance qualification is then the update of process work instructions to include the new products (sampling plan and control limits during routine operation).
My role within the validation team was to develop the OQ and PQ protocols and reports and to synchronize and support the test execution (test execution planning, operator training, ensure the Good Document Practices for the test records, etc.).
The product will be implemented in production as soon as other process steps (assembly, etc.) are validated.