COURSE ID 3110

Ethylene Oxide: Product Adoption and Parametric Release

*NEW COURSE*

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Ricardo Franco

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Ethylene Oxide (ETO) Sterilization is a critical process for medical devices, which might include pharmaceuticals and the food industry. Today, the challenge is to understand product adoption during material changes to simplify and have a more robust product validation process based on product families. Another benefit is to have a better understanding on Parametric Release to speed up the process turnaround times while reducing cost and getting material faster in the market.

This training course will focus on the specific ETO sterilization requirements of ISO 11135:2014 and how, with an effective and compliant adoption process, costs can be saved and new/revised products introduced to the market more quickly.

Upon completion of this course, you will be able to:

  • Identify and analyze requirements of ISO 11135 for product adoption and change assessment as part of the change control process by performing adoption studies for new products or products modified and have a better understanding on product adoptions versus full product validations
  • Show the benefits for Parametric Release and benefits of this method
  • Make use of procedures to evaluate and implement this method and to establish your Parametric Release Validation criteria
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This training will provide a great resource to Medical Device, Pharmaceutical, as well as Food and Science industry personnel within the following departments:

  • R&D
  • Engineering
  • Purchasing
  • Quality
  • Regulatory

Course Instructor

Ricardo-Franco

Ricardo Franco

Senior Quality Professional, Founder AMSAC Group Chem. Eng. and Sterilization SME

Ricardo Franco’s Courses

Accreditation

Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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