ATMP production is often highly manual and varied aseptic operations can occur over multiple shifts and days. Assuring operators are adequately qualified poses a unique challenge since processes can involve multiple different types of interventions which require different aseptic skills. In addition, the new Annex 1 requires for stringent qualification of operators in these processes. This presentation will cover one approach for a robust operator aseptic qualification approach that balances the changing requlatory expectations, sterility assurance requirements, and business needs. From assessing the process interventions to leveraging production data, a holistic approach is needed in the current aseptic processing environment.