ComplianceOnline

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

Instructor: Gerry O Dell
Product ID: 701929
  • Duration: 60 Min

recorded version

$279.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$379.00
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CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

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Read Frequently Asked Questions

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

Instructor Profile:

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.

Follow us :
ComplianceOnline Medical Device Summit 2017
FDA's New Import Program for 2017 - Strict Precision

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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