Software Verification and Validation in Medical Industry

    /John E.   /Lincolnspeaker of compliance global
    Speaker: John E. Lincoln
    Duration: 90 Minutes
    Product Code: 700045
    Level: Intermediate
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The verification and validation of medical industry software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of the FDA, GAMP, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. A field-tested SW V&V documentation model will be featured.

why should you attend

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.  Software is being developed for medical imaging, and even thought control of computers for individuals having disabilities restricting hand or eye movement / coordination.  The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free.  Regulatory auditors are more comfortable with delving into software issues.  Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based software verification activities.   Effective and real world software V&V is even more important in today’s resource-constrained industrial environment.  This discussion will focus on a preferred U.S. FDA documentation "model" in various applications, including ERP, in-device, as-device, process/equipment control, and cGMP data / Part 11 applications.

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Areas Covered

The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations.  The FDA and other regulatory agencies have stated that software validation can  only be accomplished effectively if “risk-based”.  How can this be done in the "real world".

This webinar will address software that is:

1) As-Product;
2) In-Product;
3) Process and/or In Production and Test Equipment; and
4) Software used to support / document the Quality System (21 CFR Part 11).

It will focus on a field-tested (FDA and EU) “model” having 11 elements of document modules that can be used for all software validation documentation.
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.

Learning Objectives

  • Verification or Validation -- FDA Expectations
  • The Project Validation Plan
  • An FDA-accepted Documentation "Model"
  • Product and Process / Test / Facilities / Equipment Software
  • V&V
  • When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
  • The FDA’s 11 Key V&V Documentation Elements
  • “White Box” and “Black Box” Validations
  • GAMP / Other Considerations


  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA/RA Professionals
  • R&D Professionals
  • Engineering Professionals
  • Production Professionals
  • Operations Professionals
  • Consultants


John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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