About
End-to-End Ethylene Oxide Sterilization Validation for Medical Devices
In a regulatory landscape where expectations on sterilization are constantly increasing and scrutiny from Notified Bodies is more rigorous than ever, mastering EtO validation is no longer optional - it is strategic.
This course provides a clear, practice-oriented roadmap to Ethylene Oxide sterilization validation for medical devices, combining regulatory requirements with real operational experience.
Designed for professionals who need both a solid theoretical framework and concrete tools for daily application, it guides participants through ISO 13485 and GMP principles to their effective implementation within Validation Master Plans, IQ/OQ/PQ activities and routine process control.
Particular attention is dedicated to the critical points that most frequently emerge during audits and technical documentation reviews: worst-case definition, change management, manufacturer accountability and subcontractor oversight.
Programme
- ISO 13485 validation requirements
- GMP validation requirements
- EtO Validation steps as per ISO 11135
- Detailed analysis of the steps, (focused on overkill method):
- VMP – Validation Master Plan
- IQ – Installation Qualification
- OQ – Operational Qualification
- VMR – Validation Master Report
- Detailed analysis of the steps, (focused on overkill method):
- How to select the worst case in validation
- When to perform a revalidation with change control management
- Support processes for the effective management of the sterilization process (controlled environments, bioburden, packaging)
- Monitoring and management of the sterilization routine
- Personnel requirements
- The crucial role of subcontractors
- Supporting procedures
- Examples and case studies
This course is intended for professionals involved in the sterilization and quality management of medical devices, including private professionals, Quality Assurance and Regulatory Affairs managers, internal and external auditors, and subcontractors operating in sterilization.
Participant experience
The course is open to participants with different levels of experience.
It is designed to support both introductory learning and the consolidation of practical skills related to EtO sterilization validation in the medical device field.
Highly interactive training, with case study discussions and open Q&A sessions.
Lecturers
Giulia Cattaneo
With a degree in Biomedical Engineering, she initially gained experience in the design of medical devices and subsequently in the field of quality. She was involved in product certification testing and, later, in the complete management of the quality system, in accordance with the UNI EN ISO 13485 standard and other company management systems (quality, environment and food). In this context, she developed supplier control, process monitoring and critical process assessment activities.
From a microbiological point of view, she has experience in bioburden and sterility analysis related to the production of medical devices, in the control and monitoring of clean rooms and in the validation of ethylene oxide sterilisation processes.
In the regulatory field, he has overseen the drafting of technical files in accordance with MDD and MDR, as well as the creation and updating of technical documentation for Personal Protective Equipment.
He currently provides consultancy services in the areas of Quality, Medical Devices and Environment.
Online Training – 3 modules
MODULE 1 | 10 November 2026 from 2:00 pm to 6:00 pm CET
MODULE 2 | 11 November 2026 from 2:00 pm to 6:00 pm CET
MODULE 3 | 12 November 2026 from 2:00 pm to 6:00 pm CET
Some days before the online training 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 20 October 2026)
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.
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
