Gmp Sterilisation For Medical Devices

AY2021/2022 Semester 2

This 13-week programme provides a complete and concise treatment of the key considerations in Good Manufacturing Practice for medical devices. The main area of concentration is in the United States (US) Quality System Regulation (QSR), which has influenced much of how quality systems are managed today including the ISO13485. The course presents the US QSR in detail giving examples on how to apply each requirement. You will understand how to construct quality documentation for medical device manufacturing. The second part of this course teaches three essential sterilisation methods commonly used in the medical device industry. These are steam, ethylene oxide and radiation sterilisation, including the vital aspects of sterilisation validation mandated by regulatory and quality system requirements. You will be required to perform casework to test your ability to apply these concepts in real scenarios