Sunset at the Beach
Software Verification & Validation Strategies 2017
(includes Part 11 update)
Software Verification and Validation (V&V) is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. U.S. FDA and ISO 13485 both require Software Verification & Validation. The FDA Quality System Regulation (21 CFR Part 820) states "Design validation shall include software validation and risk analysis." All devices automated with software will be subject to this regulation. FDA has released a revised guidance document on software which impacts medical device manufacturers. This course will help you understand software verification and validation and the impact of these new revisions on software used by medical device manufacturers. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. This course will discuss what you need to do to comply with FDA and ISO without going overboard by being excessively compliant.
The Software V&V Strategies seminar will address FDA Recognized Consensus standards regarding software including IEC 62304, Medical device software - Software life cycle processes, AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software, Application of quality management system concepts, medical device data systems, Moblile APPs, Cybersecurity, IEC /TR80002-1 Edition 1.0 2009-09, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software & AAMI TIR 36:2007, Validation of software for regulated processes, 21st Century Cures Act, software as a medical device (SaMD), and Cybersecurity,
This course will discuss methods and strategies for applying the most appropriate V & V strategy for a wide variety of software used by medical device manufacturers; thus, saving considerable time and money. This course will provide an understanding of the software V&V strategies for Device Software & Submissions, Manufacturing Software, 3rd Party & off-the-shelf (OTS) software, QC/RA statistical, Quality System, & clinical software. Case studies will be presented to facilitate the discussion. SVVP, SQAP and OTS Templates will be provided.
What you will learn:
Benefits of Attending:
: Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.
Be sure to reserve your space and room early!