Live Webinar:

Understanding the FDA's New Approach to Computer System Validation

 Tuesday, December 4, 2018

 11am ET/8am PT/4pm GMT

Presented with      Axendia   

While computer systems and technology have evolved at an exponential rate over the last 20+ years, the approach to validating them has not kept pace. Computer System Validation (CSV) can be a significant obstacle to the implementation and management of software solutions, often due to a lack of clarity from FDA on CSV expectations.

As a result, the industry’s efforts have focused on a compliance-centric approach resulting in low rates of investment in software technology to deliver automation and digital capabilities across the Life-Sciences industry. This has hampered digital transformation in the industry, a trend that the FDA has recognized and is working swiftly to help reverse.

As Life Science companies strive to achieve digital transformation, a new and streamlined approach to CSV is required. Join Axendia & Sparta Systems for this live webinar where they will discuss: 

  • The FDA’s upcoming Guidance on Computer Software Assurance for Manufacturing, Operations, and Quality System Software
  • How to apply critical thinking and risk-based principles when developing assurance approaches 
  • The level of effort required to assure computer system operation in this new paradigm
  • Specific approaches companies can use to support Manufacturing, Operations, and Quality 
  • Real-world examples from Life-Science companies using this approach
  • How to use Assurance approaches to accelerate digital transformation

Register Today

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Daniel R. Matlis

President & Founder

Axendia, Inc.

Dan has almost three decades of industry experience spanning the Health-Science value chain. He has been an active member in FDA’s Case for Quality Initiative since 2014 and has presented Axendia’s research findings to industry executives and the FDA officials. 

Paul Marini

Director of Compliance

Sparta Systems

Paul has 10+ years of Quality Systems experience, including compliance, validation, implementation & product management. Leading Sparta’s Customer Audit function, Paul frequently speaks to customers about their processes for and perspective on risk-based software validation for the Life-Sciences industry.

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