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Risk-Based Computer Software Assurance Approach for PPQS

Upcoming Virtual Courses

Objectives

Part 1: Understanding FDA’s current thinking on least burdensome approach to Computer Software Assurance (CSA)

Discover the FDA’s paradigm shift in Software Validation approach by understanding the history of traditional Software Validation and the intent of the new CSA principles.

Part 1 Objectives:

  • Discuss background of Production, Process and Quality System Software Validation
  • Define Computer Software Assurance (CSA)
  • Identify the similarities and differences between CSA and traditional Software Validation
  • Apply new paradigm CSA methods to validate PPQS Software 

Part 2: Applying Computer Software Assurance (CSA) fundamentals to your Quality Management System (QMS)

Learn how to modernize your QMS to leverage CSA Fundamentals and understand how to implement a risk-based approach to build confidence that your Production, Process and Quality System Software works as intended.

Part 2 Objectives:

  • Use critical thinking to eliminate non-value-added, burdensome validation activities from your QMS
  • Incorporate new CSA fundamentals into your validation processes 
  • Participate in creating an outline for a Validation Plan/Report

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 Production 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 education@aami.org.

Faculty

David Nelson

David has a background in Software Engineering and has 26+ years of experience developing and validating Medical Devices. He currently is an Associate Software Director for Boston Scientific Neuromodulation.  His responsibilities include managing all aspects of software development and validation including security risk.  In addition, David is a faculty member at AAMI and has been developing and instructing courses for more than 12 years.

Jeremy Jensen

Jeremy Jensen is a Fellow Software Quality Engineer in the corporate global software steward group of Boston Scientific. Currently he responsible for establishing and maintaining effective structures to ensure consistent implementation of quality systems as it relates to regulated software at Boston Scientific. He helps create and implement processes and process improvements to ensure consistent implementation of external regulated software laws, regulations, guidance’s and standards (LRGS).