Sterigenics International, Inc. Release: SteriPro Consulting Director To Serve As Trainer At Radiation Sterilization For Medical Devices Program
DEERFIELD, IL -- October 2, 2014 – Niki Fidopiastis, SteriPro Consulting Director, will serve as a trainer at the Radiation Sterilization for Medical Devices Training Program October 7-10, 2014 in Alexandria, VA.
This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. The course examines: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; the new global ANSI/AAMI/ISO 11137 series on radiation sterilization standards; integration of industry standards with the Quality System regulation; sterility Assurance Levels (SALs); auditing processes for contract laboratories and sterilizers; and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations.
Fidopiastis joined Sterigenics International in 1998 as the primary consultant for SteriPro® Consulting, and in her current position, she is responsible for leading the SteriPro Consulting team in the development and management of ISO- and FDA-compliant sterilization validations for electron beam, gamma and ethylene oxide processing. SteriPro® Consulting focuses on the pre-sterilization aspects of the supply chain, working to develop and maintain the most effective sterilization processes for products, and bringing them to market in the fastest, most efficient way possible.
Headquartered in Deerfield, Illinois, Sterigenics International LLC operates out of 43 facilities in 11 countries across the Americas, Europe and Asia and is a global leader in outsourced contract sterilization services, primarily to the medical device, pharmaceutical, food safety and high performance/specialty materials industries. As a result of its global service capabilities, and the proprietary Sterigenics GPS® platform that allows real time order tracking and just in time supply chain operation, it counts numerous Fortune 500 companies as clients, with relationships exceeding two decades.
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This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. The course examines: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; the new global ANSI/AAMI/ISO 11137 series on radiation sterilization standards; integration of industry standards with the Quality System regulation; sterility Assurance Levels (SALs); auditing processes for contract laboratories and sterilizers; and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations.
Fidopiastis joined Sterigenics International in 1998 as the primary consultant for SteriPro® Consulting, and in her current position, she is responsible for leading the SteriPro Consulting team in the development and management of ISO- and FDA-compliant sterilization validations for electron beam, gamma and ethylene oxide processing. SteriPro® Consulting focuses on the pre-sterilization aspects of the supply chain, working to develop and maintain the most effective sterilization processes for products, and bringing them to market in the fastest, most efficient way possible.
Headquartered in Deerfield, Illinois, Sterigenics International LLC operates out of 43 facilities in 11 countries across the Americas, Europe and Asia and is a global leader in outsourced contract sterilization services, primarily to the medical device, pharmaceutical, food safety and high performance/specialty materials industries. As a result of its global service capabilities, and the proprietary Sterigenics GPS® platform that allows real time order tracking and just in time supply chain operation, it counts numerous Fortune 500 companies as clients, with relationships exceeding two decades.
Help employers find you! Check out all the jobs and post your resume.