The course gives an outline of industrial sterilization of medical devices and how to define and implement sterilization into product development and manufacturing. The course gives a basic introduction to industrial sterilization of medical devices. The course will focus on the different industrial sterilization methods used for medical devices but also briefly describe other sterilization methods used within the medical device industry. The key purpose of the course is to make the participants able to make a qualified initial choice of the most suitable sterilization method for their device in question.
 
The course will look into the most common design challenges related to sterilization and will make the participants able to understand the implications of the choice of materials. On an overall level, the course will give input to sterilization validation approach, and will give the participants a practical insight to sterilization project management. Finally, the course will give an overview of the key international standards within sterilization area including other associated sterilization relevant standards.
 
Content
The learning goals of the course are to:

• Provide a basic knowledge of the most common industrial sterilization methods and associated microbiological tests
• Provide an introduction to the design of medical devices in relation to the choice of sterilization method
• Provide an overall knowledge of the key international standards for sterilization
• Increase knowledge of the most common pitfalls within the sterilization area

The course comprises lectures and interactive workshops. The trainer will follow up on learning objectives throughout the course. This means that the participants will have to answer questions on the topics covered to ensure that the learning goals are met.

Who should attend
The course is targeted towards professionals who are involved in the following areas:

• Development of medical devices
• Project Managers within the medical device industry
• Quality Assurance
• Quality Control
• Supply chain

There are no pre-requisites but it is helpful to have experience from the medical device industry or other regulated industry.
 
Trainers
Pavla Frey, Senior consultant, Pharma4ever QA ApS
Søren Lyngsø-Petersen, Director at Pharma4ever QA ApS
Ulla Holm Christensen, Project Manager, Novo Nordisk