Companies delivering sterile medical devices to the marketplace need to comply with international regulations governing the provision of sterility in the medical device industry. From initial validation to ongoing surveillance, this course teaches you how to comply and navigate the process of securing and maintaining sterility of your device.
Obtain detailed knowledge of the key terms, processes and requirements for the microbiological validation, control, and testing of sterile medical devices in order to maintain compliance with international regulations.
How will I benefit?
- Gain a stronger application of the requirements for control of sterile devices
- Recognize how the requirements fit together to support device sterility in the marketplace
- Demonstrate compliance with international regulations by executing correct methodologies
- Form a foundation for on-going sterile device control
Who should attend?
This course is suitable for anyone working within:
- Quality Assurance
- Regulatory Affairs
- Sterilization Management
- Packaging and Environmental Engineering
What will I learn?
By the end of this course, you will know:
- Key concepts and terminology of microbiological validation
- Principles of sterilization validation
- Aseptic processing
- Gamma irradiation
- Electron beam radiation
- Vapour phase hydrogen peroxide
- Ethylene oxide sterilization
- Principles of environmental control including testing and monitoring to support processes
- Principles of packaging shelf life validation
What's included?
- Detailed course notes
- Lunch provided
- On completion, you’ll be awarded an internationally respected BSI Training Academy certificate
