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Medical devices: correct handling of non-compliant model
February 27, 2023 @ 2:30 PM - 3:30 PM
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.
Webinar goals
- Understand the context of non-conformities within a Quality Management System
- Define the non-compliant product
- Internalize the flow of the non-conformity management process
- Describe the fate and disposal of a non-compliant product
- Define the concept of rework of a non-compliant product
Target group
Quality Assurance/Regulatory Affairs of medical device manufacturers and contract medical device manufacturers
What we learn from the webinar
The correct approach to dealing with non-compliant medical device cases
Program
- General aspects
- Regulatory framework
- Control of a non-compliant product
- reworking
Lecturer
Federica 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.
