Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

Risk Management; Software

Date: 27 May '20
Time: 10:00am to 1:00pm (GMT-08:00) Pacific Time (US and Canada); Tijuana
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This software verification and validation training will discuss how to develop / implement formal software Verification and Validation methods for devices, production and test equipment and electronic records / signatures / Part 11 to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters. US FDA, Several standards and industry recommendations will be described in this V&V methods.

Why Should You Attend

Software / firmware and related hardware design, development, testing / verification and validation is difficult to structure, manage, document and control. For many companies the subject can be intimidating. Software design and development is under increased scrutiny by the U.S. FDA. Software V&V issues are becoming a growing area of concern by all regulatory agencies worldwide. Product, production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. A comprehensive, corporate wide plan, accompanied by proper implementation and documentation, 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 regulatory (FDA and EU) expectations be met?

  • What V&V is necessary to minimize software failures in the field or in-house?

  • How to use the FDA's own "model" to document all types of SW V&V.

  • How to use this model to add predictability to bring software V&V in under budget and within project timelines.

  • The US FDA requires that all device, production / test / lab equipment, and processes using software / firmware be validated (e.g., 21 CFR 820.70i). Similar for the EU. This presentation focuses on the planning and execution of system-level software verification and validation, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions), that has been field-tested for over 20 years, will be defined, evaluated, implemented, with V&V documentation 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, and 4) QMS / 21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.

Areas Covered in the Webinar

  • U.S. FDA's expectations
  • Tougher FDA Expectations / Requirements
  • Data Integrity and Cybersecurity
  • Roles of Verification and Validation; Legal requirements; Recommended “best practices”
  • A 21-year long, field-tested FDA "Model"
  • A Typical Software V&V Protocol / Test Report; "Black" and "White" box testing
  • 21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
  • Expected Regulatory Deliverables
  • Major areas of industry failure
  • Standards and industry-recommended Guidelines

Who Will Benefit
  • Senior and middle management.
  • Quality Assurance
  • Regulatory Affairs
  • R&D
  • Engineering
  • Software engineering
  • Programmers
  • Sales and Marketing
  • Operations / Production


John E Lincoln

Principal, J E Lincoln and Associates



Ashutos Swain