Designing an Effective Cleaning Validation for Reusable Medical Devices in Today’s Regulatory Environment
Why Should You Attend:
Reusable medical devices are receiving more and more scrutiny from regulatory agencies both in the United States and internationally. Sometimes it seems that the requirements for an acceptable cleaning validation are changing on a daily basis. Knowing the latest expectations is critical for a manufacturer so that they can reduce the likelihood that their submission will not be accepted and require additional testing or worst case that it will need to be repeated.
This presentation will address the most current expectations for cleaning validations of reusable medical devices that are performed in support of the instructions in the instruction for use (IFU). It will include both manual and automated cleaning processes as well information on how to choose test soils, markers for challenging cleaning and the acceptance criteria to use to establish effective cleaning.
Areas Covered in the Seminar:
- Cleaning validation design – automated cleaning.
- Cleaning validation design – manual cleaning.
- IFU information to be supported.
- Choosing test soils.
- Choosing markers.
- Expectations for controls.
- Acceptance criteria selection.
- Report preparation.
