Niki Fidopiastis, SteriPro’s consulting director, will serve as a trainer at the Radiation Sterilization for Medical Devices Training Programme from October 7-10 2014 in Alexandria, VA.
The three and a half day programme covers principles, processes, industry best practices, and industry standards in radiation sterilisation 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 sterilisation and the new global ANSI / AAMI / ISO 11137 series on radiation sterilisation standards.
It also includes the integration of industry standards with the Quality System Regulation; sterility assurance levels (SALs); auditing processes for contract laboratories and sterilisers, and radiation sterilisation processing.
Radiation sterilisation processing includes safety precautions, characteristics, constraints, and the impact of radiation operations.
Fidopiastis joined Sterigenics International in 1998 as the primary consultant for SteriPro® Consulting.
She currently leads the SteriPro consulting team in the development and management of ISO and FDA-compliant sterilisation validations for electron beam, gamma and ethylene oxide processing.
SteriPro consulting focuses on pre sterilisation aspects of the supply chain, by working to develop and maintain the most effective sterilisation processes for products, and bringing them to market in an efficient manner.