Course Description: 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.
- AAMI Members: $1980
- Nonmembers: $2200
- Government Employees: $800
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.
Target Audience: 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.
Format: A combination of situation analyses, case-study exercises, review of sample recall and warning letters, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.
Materials: Fee includes a copy of the AAMI/ISO TIR80002-2 Medical Device Software – Part 2: Validation of Software for Medical Device Quality Systems, several FDA guidance documents related to software validation, the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.