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 and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series radiation sterilization standards.

Participants will understand FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance and scientific theory and principles of radiation sterilization. The course examines the global ANSI/AAMI/ISO 11137 series on radiation sterilization standards. Participants will learn integration of industry standards with the 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. 

This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles. 

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.