The Most Common Problems in FDA Software Verification and Validation

John E Lincoln Instructor:
John E Lincoln 
90 Minutes
Webinar ID: 500927

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Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, 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.

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 for 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 in under budget and within project timelines.

Areas Covered in the Session:

  • Major 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

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

Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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