Over the course of the 3 days, the attendee will acquire a robust foundation and knowledge in:
Understanding industrial sterilization applications of 100% Ethylene Oxide (EO) and, common Irradiation methods, including Gamma and E-beams;
Addressing the requirements of EN 556-1, ISO 11737, ISO 11135, and ISO 11137
Defining the SAL (Sterility Assurance Level) for a medical device;
Understanding the microbiological aspects of bio-burden and sterility assurance;
The fundamentals to be laid down in order to support technical file review of sterilization validation documentation and;
The development, validation and routine control of a sterilization process for medical devices;.
About the Trainer
Lead Auditor and Trainer
Chris Justi is a qualified notified body auditor with GMED North America. His 23 years of experience includes working in design and development of new sterilization technology, within global contract sterilization services, and the managing of several sterilization programs within 2 large medical device manufacturers. He has earned multiple certifications in the areas of medical device sterilization and quality system auditing.
Fully owned subsidiary of GMED SAS. • GMED, Notified Body n° 0459
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