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A Paradigm Shift in Non-Product CSV: An Industry – FDA Update

On-Demand Webinar

If you are a medical device firm that has invested in an electronic system, or are an FDA investigator, Third Party or Notified Body Auditor, then you can’t afford to miss this webinar.

Medical Device

What is the biggest barrier holding firms back from realizing value from their IT investments and unleashing significant innovation and improvement? When asked this question at a 2015 Siemens PLM Executive Roundtable event, the executives zeroed in on non-product CSV. Over the years, the perception of CSV’s purpose and level of assurance activity for non-product software has drifted significantly increasing the time, resources, and cost of implementing and maintaining software. Validation has been treated as a “catch all” term associated with any type of computer system with a very prescribed set of expectations for how it is demonstrated. This perception creates resistance and burden for adoption of technologies that can reduce errors, drive traceability to find issues faster, and find connections or opportunities faster.

Working with FDA, a cross-industry team was formed shortly after 2015 Executive Roundtable event to clarify misperceptions causing these issues. In this webinar, representatives from the team will share examples of streamlined non-product CSV risk-based approaches you can leverage to improve the quality of your assurance activity, while significantly reducing the cost and time. In addition, you’ll hear success stories from a medical device firm that has automated and error-proofed CSV, as well as another firm that saw a 91% reduction in PQ execution time.

Please join the FDA, Boston Scientific, Baxter Healthcare, Medtronic, Zoll Lifevest and Siemens PLM for a provoking webinar that will change the game.

As this webinar is over 2 hours, for easier navigation here are the various sections:

  • Background, Overview, and Business Case (FDA and Siemens PLM)
  • Streamlined Risk Based Recommendation: Leveraging Vendor Qualification (Boston Scientific) – Begins at minute 24:00
  • Streamlined Risk Based Recommendation: Using Ad Hoc and Unscripted Testing (Boston Scientific and FDA) – Begins at minute 32:50
  • Streamlined Risk Based Recommendation: Analytics and Reporting (Baxter Healthcare and FDA) – Begins at minute 52:50
  • An FDA Collaboration CSV Success Story (Zoll Lifevest and FDA) – Begins at minute 1:04.00
  • Automating CSV Risk Management (Medtronic) – Begins at minute 1:24.35
  • Next Steps and Q&A (FDA and Siemens PLM) – Begins at minute 2:02.00
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