2-day In-person Seminar: Medical Device Sterilization: Corrective & Preventive Action

Sterilization is a critical aspect of device approval and release. Though this is indeed fact, manufacturers sterilize product as a matter of course, without expert sterilization assurance personnel to guide them through potential problems in sterilization. As the world and meaning of CAPA continue to evolve in the medical device industry, further misunderstanding arises when faced with determine root cause and corrective (or preventive) action for any variation in this critical process in device manufacture.

The course will begin with an overview of EO sterilization, explaining which aspects of the process often cause confusion. This will be followed by process validation and what paperwork is required to provide ‘documented evidence’ ; and finally what are typical deficiencies encountered in the EO process. Next a detailed explanation of Radiation Sterilization will be given. Specific to Radiation Sterilization is the required sterilization dose, which will be covered in depth – how to determine sterilization dose and how to maintain the validated dose. Process validation will be covered as well as the typical deficiencies encountered in Radiation Sterilization and Validation. Critical and non-critical deficiencies will be covered and when this should trigger a CAPA. Finally contract sterilization will be reviewed with the specifics of how to deal with CAPA when you are not directly responsible for sterilization.