The Most Common Problems in FDA Software Verification and Validation

John E. Lincoln
From: Oct 11, 2022 - To: Dec 31, 2022
Recorded Webinar


Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on software verification and validation planning and execution, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.

A suggested FDA model (mandated for submissions) will be evaluated, and implemented, with the 11 key V&V documentation requirements and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) In-product, 2) As-product, 3) Production / Test, 4) QMS / 21 CFR Pt. 11, and 5) Cybersecurity issues. Field examples, good and bad will be addressed. Evaluation of the chief problem areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.

Areas Covered:-

  • Significant areas of industry failure
  • Tougher FDA Expectations / Requirements; Cybersecurity
  • Roles of Verification and Validation
  • An FDA "Model"
  • A Typical Software V&V Protocol / Test Report; "Black" and "White" box
  • A Brief Overview of 21 CFR Part 11, and its implementation
  • Legacy, Hybrid, New, and ER / ES Systems
  • Expected Regulatory Deliverables
  • Complementary Guidelines

Why You Should Attend:-

Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becoming a growing area of concern by regulatory agencies. Product, production/test equipment, and even the QMS are heavily software/firmware driven in today's manufacturing. Yet many of the same problems in software V&V are found by FDA inspections. A key Guidance document is often ignored. 11 required documents are missing. A comprehensive, corporate-wide plan is a necessity. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment, demanding a product risk-based approach. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V under budget and within project timelines.

Who Will Benefit:-

  • Senior Management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • Engineering, R&D, and Software Development and Testing Teams

Training Options

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