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DTSTART;TZID=Europe/Rome:20230227T143000
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DTSTAMP:20260521T032544
CREATED:20230214T212730Z
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UID:11413-1677508200-1677511800@biopmed.eu
SUMMARY:Medical devices: correct handling of non-compliant model
DESCRIPTION:Starting from the general definition of non-conformity of a medical device\, we will focus on how to manage a situation of this type\, illustrating the process of managing the rework and/or disposal phases.\nRegister \nWebinar goals\n\nUnderstand the context of non-conformities within a Quality Management System\nDefine the non-compliant product\nInternalize the flow of the non-conformity management process\nDescribe the fate and disposal of a non-compliant product\nDefine the concept of rework of a non-compliant product\n\nTarget group\nQuality Assurance/Regulatory Affairs of medical device manufacturers and contract medical device manufacturers \nWhat we learn from the webinar\nThe correct approach to dealing with non-compliant medical device cases \nProgram\n\nGeneral aspects\nRegulatory framework\nControl of a non-compliant product\nreworking\n\nLecturer\nFederica Carra. Graduated in Chemistry and Pharmaceutical Technology at the University of Turin\, she has twenty years of experience in Pharmaceutical Quality Control\, during which she obtained recognition for the suitability of a Qualified Person. Since 2016 he has been collaborating with Chemsafe for the design\, Development and maintenance of ISO 9001 certification as Quality Manager and in the design and development of quality management systems for manufacturers of medical devices in accordance with current legislation. He is auditor of first and second part of Quality Management Systems GMP\, ISO 9001\, ISO 13485\, ISO 22716\, ISO 15378. \nRegister
URL:https://biopmed.eu/en/evento-en/medical-devices-correct-handling-of-non-compliant-model/
LOCATION:Online
CATEGORIES:bioPmed events
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