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.
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.
Who Should Attend?
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.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email email@example.com.
Senior Faculty, AAMI
Mr. Walker is a senior faculty member for the Association for the Advancement of Medical Instrumentation (AAMI) and has been teaching since 2012. He is a contributing author for The Quality System Compendium: CGMP Requirements and Industry Practice, Fourth Edition. He has provided consulting services for over 25 years to Medical Device, Pharma and Biotech companies on FDA's Quality System Regulation (21 CFR 820) and ISO Quality Management system (ISO 13485) to include regulatory compliance, computer systems validation, medical device software design and development, equipment qualification, internal and supplier auditing, quality system development, quality system training, general IT and risk management services.