Industrial Sterilization of Medical Devices – An Introduction to the Practical Approach of Sterilization

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.

Course objective and outcome

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

Trainers

Pavla Frey, Senior consultant, Pharma4ever ApS

Søren Lyngsø-Petersen, Senior consultant, Pharma4ever ApS

Ulla Christensen, Project Manager, Novo Nordisk

What previous participants said

Contact

Morten Petersen

Uddannelseskonsulent

49 18 47 03
mp@medicoindustrien.dk