Changes to Ethylene Oxide sterilization in the new ISO 11135:2014

Duration: 60 Minutes
This webinar will speak about the latest amendments to the ISO 11135 for sterilization using ethylene oxide.
Ethylene Oxide Sterilization
Instructor: Mark Roberts
Product ID: 500891

Previously the requirements and guidance were split between ISO 11135-1:2007 and ISO/TS 11135-2:2008. This has now been merged into one document, ISO 11135:2014. The new standard not only merges the two prior standards, but also adds and changes some key requirements. Some changes may impact your existing validation or expectations from your contract sterilizer.

The areas covered in the webinar include:
  • Changes to equipment requirements
  • Product and Process definition changes
  • Validation updates
  • Revalidation changes
  • Routine monitoring and release updates
  • Changes to the guidance / annexes
Why Should you Attend:
ISO 11135:2014 is already recognized by the FDA and will be harmonized for the rest of the world in the next 3 years. Changes have impact on your validations, revalidations and routine process control. This presentation will let you understand the changes and determine the impact on your sterilization processes.

Objectives of the Presentation:
The key objectives of the presentation are to:
  • Understand the timing of the change
  • Determine what to expect from your contract sterilizer
  • Determine impact of the changes on your validation/revalidation
  • How to prepare an action plan to implement the changes
  • Find out if there will be any impact on routine sterilization processes
Who can Benefit:
  • Medical Device and IVD Manufacturers
  • RA/QA
  • Microbiology
  • Sterilization Specialist
$375
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÜV SÜD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits and product/sterilization file reviews for notified bodies on a contract basis. He has 30 years of experience in the medical device industry.

Prior to joining TÜV he was with Becton Dickinson in their corporate offices as manager of sterility assurance. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA.


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