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Mon, Apr 04


Online Training

Production & Quality System Software

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.

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Production & Quality System Software
Production & Quality System Software

Time & Location

Apr 04, 2022, 7:00 AM – Apr 05, 2022, 11:00 AM

Online Training

About the event

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.

This course is designed for software developers, quality engineers, auditors, process engineers, manufacturing engineers, quality assurance and regulatory compliance personnel, or others involved in the use of Process and Quality System Software and responsible for meeting industry standards and FDA requirements.

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