Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Instructor:
Gerry O Dell
Product ID: 701929
- Duration: 90 Min
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 Webinar:
- 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.
Who Will Benefit:
This webinar will provide valuable information to all companies that manufacture reusable medical devices in environments:
- QA personnel
- Validation specialists
- Regulatory Affairs
- R&D Personnel
- Cleanroom Managers and Staff
Gerry O Dell
President, Gerry O’Dell Consulting
Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-nine years of experience in the medical device industry.
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