envelope  Contact us


Validation and Control of the Sterilization Process for Ethylene Oxide & Irradiation

Course Objectives

Picto control of the sterilization process for ethylene oxide and radiationThis program is designed to help attendees to:

  • Gain an understanding of the differences between Ethylene Oxide and Irradiation sterilization processes, their mode of action and their factors of influence.
  • Acquire methodology as well as the technical and documentary tools required to validate, implement, control and audit the sterilization process by ethylene oxide or irradiation.
  • Manage and control contract sterilization activities and satisfy regulatory requirements.



Sterilization Validation (EtO and Irradiation)

  • Overview of the Sterilization Process
  • Microbiological Tests Used to Validate the Sterilization Process
  • Sterilization Process: Radiation Sterilization
  • Ethylene Oxide Sterilization
  • Innocuousness Testing

Cleaning, Decontamination, and Disinfecting Medical Devices

  • Regulatory and Standard Context, Environment
  • Equipment Identification and Qualification
  • Validation
  • Requalification
  • Cleaning Process
  • Analysis methods and techniques
  • Managing changes and modifications
  • Risk Analysis

Training Application Form

* Required field

combo ISO 13485 9001


We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States


lne gmed arrow Submit a request

clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

 Calendar Notified Body 06 06

Santa Clara, CA