Read Frequently Asked Questions
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
This webinar will address the most current (regulatory) expectations for cleaning validation of reusable medical devices that are performed in support of the instructions in the instruction for use (IFU).
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, 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.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.
We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email email@example.com or call +1-888-717-2436(Toll Free).
This training hasn't been reviewed yet.
Gerry O Dell
Ethylene Oxide (EO) Sterilization Basics for R&D Engineers Basics of Testing Associated with Sterilization Validation and Routine Processing Failure or OOS Investigation for Sterility or Bioburden Testing How to Investigate Environmental Monitoring Excursions