Device Software Verification and Validation - Webinar CD/Transcript

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Device Software Verification and Validation: What Is Now Required Under ISO 13485:2016

Do you know the ins and outs of the new, revised ISO 13485 standard?

After 13 of years of the same old, same old, manufacturers will need to make adjustments — new emphasis has been placed on the validation of Quality Management System (QMS) software.

How do these new requirements fit in with FDA guidances, GAMP 4/5 and 21 CFR 11?

Veteran FDA consultant, John Lincoln demonstrates a preferred FDA 11-element documentation model in various applications including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications.

After attending this 90-minute session you will come away with an understanding of:

  • Developing and creating buy-in for a project validation plan
  • Understanding what the FDA accepts as an appropriate documentation model
  • Beyond just in-product software V&V — understanding the FDA’s expectation for your testing software, ERP software and more
  • When and how to use DQ, IQ, OQ, PQ or their equivalents
  • How GAMP 4/5 requirements fit into your V&V planning and execution
  • Detailing the FDA’s 11 key V&V documentation elements:
  • Level of Concern
  • Hazard/Risk Analysis
  • Software Description
  • SRS (Software Requirements Specification)
  • Architecture
  • Design Specification
  • Traceability (Matrix; Paragraph Numbering)
  • Development
  • V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs)
  • Revision History and Release Number
  • Unresolved Anomalies ('Bugs')
  • “White Box” and “Black Box” validations
  • And much more

Order today for a clear understanding of FDA investigators expectations and how to meet them.

  • QA/RA
  • Software development, programming, documentation, testing
  • R&D
  • Engineering
  • Production
  • Operations     

John Lincoln, Principal of J.E. Lincoln and Associates LLC
John Lincoln has nearly 20 years experience as an FDA consultant. As Principal of J.E. Lincoln and Associates LLC, John has worked with start-ups through Fortune 100 companies in the U.S., Mexico, Canada, France, German, Sweden, China, and Taiwan. John has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, and Director of R&D. As a frequently published author, he also writes a column for the Journal of Validation Technology.