Virtual Training

Ethylene Oxide Sterilization for Medical Devices

August 30 - September 2

This highly interactive 28-hour advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios.

Topics to be covered include:
validation and requalification;
validation reports, protocols, and documentation;
product adoption;
troubleshooting;
process changes and process equivalency;
product release methods;
and optimization of sterilization process.

https://www.aami.org/training/training-suites/sterilization/ethylene-oxide-sterilization

Virtual Training

Industrial Sterilization for Medical Devices

September 27 to 30

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;
select and implement an appropriate sterilization process;
and identify the elements of a successful sterilization validation

Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

https://www.aami.org/training/training-suites/sterilization/industrial-sterilization-for-medical-devices

Virtual Training

Radiation Sterilization for Medical Devices

October 25 to 28

This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are:

FDA expectations regarding successful submissions, inspections, recalls, problem solving, and risk avoidance
Scientific theory and principles of radiation sterilization
The 11137 series of radiation sterilization standards

Participants will learn integration of industry standards with the U.S. Quality System Regulation, auditing processes for contract laboratories and sterilizers, and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations.

This course is designed to be highly interactive between faculty and participants and will include relevant real-life examples and “hands-on” exercises from a broad spectrum of medical device products.? The course includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.

https://www.aami.org/training/training-suites/sterilization/radiation-sterilization-for-medical-devices