Introduzione

Ethylene oxide sterilization is one of the most widely used and key processes in the production of sterile medical devices.

The MDR (EU) 2017/745 & IVDR (EU) 2017/746 require specific requirements for devices supplied or intended to be used in a sterile state. To comply with these requirements, it is important to understand the principles of ethylene oxide sterilization processes and how to monitor a validation process for the medical devices produced.

During this training course, you will go in-depth with the Ethylene oxide sterilization process, and understand the importance of controlling microbial contamination, and maintaining sterility over time with appropriate sterile barrier systems.

Once completed, you will have the confidence to oversee ethylene oxide sterilization processes and how to comply with the related regulatory requirements.

During this workshop, we will address the following topics:

  • Introduction to microbiology
  • Sources of microbial contamination
  • Contamination control
  • Monitoring the packaging
  • Monitoring the life cycle of a sterile medical device until its use
  • Ethylene oxide sterilization principles
  • Ethylene oxide sterilization cycles
  • Biological indicators
  • Validation of sterile medical devices
  • Impact of the changes on the validated process
  • Monitoring the outsourced sterilization
  • Regulatory and standards requirements
  • Preparation of audits by Notified bodies (expectation for the technical documentation)

Personnel working in Medical Device companies, such as Quality Management System professionals, Regulatory Affairs professionals, QA/RA people, Validation engineers, Production responsible, Microbiologists and sterilization professionals.

Participant experience 
Basic knowledge of the quality management systems standard ISO 13485:2016 and European Medical Devices Regulations (MDR 2017/745 and IVDR 2017/746), as well as basic knowledge of the manufacturing of sterile medical devices, are recommended.

Online training course, in small groups to share real-life experience between attendees and trainer.
Questions and subsequent discussion are welcome at any time during the training.
Some exercises will be proposed during the training.

Docente/i
Elem Ayne
Info

Elem Ayne

QA/RA Consultant – ACR Medical

Elem Ayne got a professional degree in industrial microbiology and biotechnology. She has started her carrier in R&D in oncology, then she worked many years in sterilization before specialising in Quality Assurance/Regulatory Affairs.
Elem Ayne, has 8 years’ experience in the field of compliance of technical documentation and quality systems. She has also a number of professional experiences in the field of ethylene oxide and steam sterilisation, gained with ethylene oxide and steam autoclave manufacturers. She is the President of TEAM-PRRC, the European non-profit organization for Persons Responsible for Regulatory Compliance (PRRC). She has founded TEAM-PRRC in 2020 with some other experts to help PRRCs to assume this new profession which has considerable responsibilities, but also to develop a high level of professionalism of PRRC.
She is also an entrepreneur, she has founded her own consulting company ACR MEDICAL in 2019 and works as a consultant, an auditor and a trainer. She earned 3 master’s degrees: in Medical Device & Regulatory Affairs, Business Development and International Marketing in health industries.


Online Training – 3 modules

MODULE 1 | 03 November 2025 from 2:00 pm to 6:00 pm CET
MODULE 2 | 04 November 2025 from 2:00 pm to 6:00 pm CET
MODULE 3 | 05 November 2025 from 2:00 pm to 6:00 pm CET

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 1.295,00* (until 13 October 2025)

Ordinary: € 1.510,00*

Freelance – Individual – Academy – Public Administration: € 895,00*

* for Italian companies: +22% VAT

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Know the definition of sterile medical devices (Sterility Assurance Level) and what is Ethylene Oxide.
Risultato atteso
Understand the microbiological requirements before and after the sterilization process.
Risultato atteso
Understand the validation process and meet regulatory requirements (MDR and IVDR) for its use.
Risultato atteso
Understand the control of an outsourced sterilization.
Risultato atteso
Be aware of Notified Bodies expectations, and be prepared for audits.

<p>Online interactive training on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

<p>Online interactive training on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>