This course is designed to understand what is and what is not production and quality system software that is required to be validated by FDA and ISO 13485 and will show the methods and tools used to validate Process and Quality System using a software lifecycle process.
Program Objective
Participants will learn about the software life cycle of Production and Quality System software used for the various elements of Medical Device Quality Management System, Calibration, design and development of medical devices, manufacturing and automated production systems software. The course covers the basic elements and strategies for efficiently conducting software validation as required by 21CFR820, ISO 13485, and MDSAP.
In addition, participants will learn how to select the appropriate tools from the applicable technical information report (ISO 80002-2) and guidance (GPSV) for automated production system software, enterprise, custom developed, off-the-shelf (OTS), spreadsheet, and cloud-based applications.
For more information: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007VSXE