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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.

 

Program

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

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combo ISO 13485 9001

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

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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.

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