Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Instructor:
Gerry O Dell
Product ID: 701929
- 10
- February 2025
Monday - 10:00 AM PT | 01:00 PM ET
Duration: 90 Min
Why Should You Attend:
Reusable medical devices continue to receive scrutiny from regulatory agencies both in the United States and internationally. Since the advent of ANSI/AAMI ST 98 there has been more clarity in how to perform these validations but it is still important to know the regulatory expectations to reduce the likelihood that submissions will not be accepted and require additional testing or worst case that the testing needs 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 as 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
- R&D
Gerry O Dell
President, Gerry O’Dell Consulting
Gerry O'Dell, is Co-owner and Technical Director for O'Dell & Hodge Consulting, LLC a consulting firm based in the United States with medical device and pharmaceutical clients around the world. She spent approximately 26 years consulting to companies of all sizes assisting them to comply with requirements at all stages of the development and manufacturing process for any sterilization modality. Then in 2024 she joined with Samantha Hodge to form O'Dell & Hodge Consulting and continues to consult in the realm of sterilization and microbiology. Prior to consulting Gerry worked for Johnson & Johnson as a 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. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over 41 years of experience in the medical device industry.
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