How Will FDA’s New Approach to CSV Make Implementations Easier?

A Free FDAnews Webinar • Sponsored by ComplianceQuest
Thursday, Dec. 3, 2020 • 1:30 p.m. - 2:30 p.m. EST

There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) is still expected within 2020. Its focus is taking the principles from Quality Risk Management and applying that same logic to computer systems. In this webinar, we will dissect the new CSA approach and explore the key matrices/tools needed to make solid risk determinations thus providing the framework needed to streamline computer platform implementations and on-going maintenance. In the final analysis, there are key questions that must be applied for CSA to be effective. Does the software impact patient safety? Does this software impact product quality? How does this software impact your quality system integrity?

Learn in this Webinar:

  • What is Computer Software Assurance for Manufacturing, Operations and Quality Systems Software?
  • What is critical risk thinking?
  • Understand the differences between CSA and CSV model.
  • What computer systems does CSA apply?
  • What performance metrics do I need?
  • When do I need to be prepared for the new approach and final guidance / regulations?
  • Where to start in your transition and next steps?

Who Will Benefit

  • Quality professionals
  • Compliance professionals
  • IT professionals

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Meet Your Presenter

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Tim Fischer

Principal Partner
Great Solutions, LLC

Tim Fischer has been in the Life Science compliance arena for 30 years. Beginning his career at Abbott Labs in North Chicago IL in lab operations, manufacturing and technical support, he was able to build on that experience and spent several years as Director of Compliance for 3 different contract manufacturing organizations. He then began working directly with compliance software platforms including Pilgrim, ETQ and PrisymID as an Industry SME and now manages a consulting group focused on computer system vendor validation as well as GMP quality systems auditing and remediation.