Sharpen Your Understanding of Medical Device Sterilization Principles, Standards, and Regulations.
Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.
Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for ethylene oxide (EO) and radiation sterilization, and will also be introduced to the general process validation methods for other sterilization methods such as nitrogen dioxide, vaporized hydrogen peroxide, etc. Participants will explore processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.
Participants will learn how to...
- apply the principles of sterilization and address requirements during product design;
- select and implement an appropriate sterilization process;
- and identify the elements of a successful sterilization validation
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email firstname.lastname@example.org.