AAMI Presents: Risk-Based Computer Software Assurance Approach for PPQS
Part 1: Understanding FDA’s current thinking on least burdensome approach to Computer Software Assurance (CSA) | Tuesday, November 28th | 1:00-3:00 pm Eastern
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) | Thursday, November 30th | 1:00-3:00 pm Eastern
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