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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.



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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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations


European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager