Course Details
Scheduled Events: June-July 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
European Regulation 2017/745 states: “Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.”
Again: “Devices labelled as sterile shall be processed, manufactured, packaged and, sterilized by means of appropriate, validated methods.” and “Devices intended to be sterilized shall be manufactured and packaged in appropriate and controlled conditions and facilities.”
Therefore, it is important to grant the final sterility of the medical device by monitoring the whole process from the incoming of raw materials, throughout the manufacturing in appropriate clean environment, by using a validated packaging system and sterilization process.
This training is divided into the following seven modules, which address in detail all the aspects and factors that contribute to ensuring the sterility of medical devices declared sterile:
- Module 1 - Basic microbiology and main microbiological tests applicable to medical devices (code MMCRO)
- Module 2 – The terminal sterilization process of medical devices by ethylene oxide: validation and routine control (code METL)
- Module 3 – The terminal sterilization process of medical devices by irradiation: validation and routine control (code MIRR)
- Module 4 – The terminal sterilization process of medical devices by moist heat: validation and routine control (code MMOI)
- Module 5 – Terminal sterilization by dry heat and the dehydrogenation of medical devices: validation and routine control (code MDRY)
- Module 6 – Controlled contamination environments for medical devices manufacturing: classification, validation, and monitoring (code MCLE)
- Module 7 – The Packaging of sterile medical devices (code MPKG)
The overall objective of this training is to provide basic information and tools useful for validating sterilization processes, ensuring their control and facilitating the interpretation of sterilization documentation, even in case of outsourced process.
Who should attend?
The course is intended for managers and members of the Quality Assurance, Regulatory Affairs, Production, and Quality Control teams who handle sterile medical devices. Basic knowledge will also be provided for new hires and those who, despite having handled sterile medical devices for a long time, have identified the need to consolidate their training in these topics.
Course Agenda
Check the individual modules' pages to see the agenda:
- Module 1 - Basic microbiology and main microbiological tests applicable to medical devices
- Module 2 – The terminal sterilization process of medical devices by ethylene oxide: validation and routine control
- Module 3 – The terminal sterilization process of medical devices by irradiation: validation and routine control
- Module 4 – The terminal sterilization process of medical devices by moist heat: validation and routine control
- Module 5 – Terminal sterilization by dry heat and the dehydrogenation of medical devices: validation and routine control
- Module 6 – Controlled contamination environments for medical devices manufacturing: classification, validation, and monitoring
- Module 7 – The Packaging of sterile medical devices
Prerequisites
None.
Course Materials
- Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
- Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.
Learning Assessments
- Certificate of competence, in case of successful completion of final exam
- Certificate of attendance, in case of non-successful completion of the final exam or no exam.
Duration
29 hours divided into 7 modules. The training can be attended in its entirety or by selecting only the modules of interest. For details, check the individual module pages above.
Scheduled Events
- 16-17, 23-24-25, 30 June and 01 July 2026, 09:00 am - 01:00 pm (CEST).
Price
3200,00 € (per participant, taxation excl.).
Learning Mode
Online, Instructor-Led
Language
Training in English Language
