Achieve a Competitive Edge
Through Quality Metrics

An FDAnews FREE Webinar • Sponsored by Dassault Systèmes BIOVIA
Recorded May 30, 2017

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The goal of the revised quality metrics guidance is the collection of quality metrics data from life science companies to foster the FDA’s aim for risk-based inspection planning.

How does the FDA intend to use the quality metrics data?

What data are the FDA proposing is reported?

Attend this webinar to learn what steps you need to take to prepare for the FDA Quality Metrics Program.  By the end, you’ll:

  • Understand the FDA’s Quality Metrics Vision
    • CDER and CBER perspectives
    • Voluntary phase
    • Compliance versus quality
  • Learn How to Develop Enterprise-Wide Quality Metrics for Product Lifecycle
    • Keep it cost-effective
    • Validate your models and systems
    • Balance lagging versus forward quality indicators
    • Determine which metrics matter: Key Performance Indicators
  • Link to Lifecycle Process Validation
    • Begin with QbD
    • Install continuous verification scheme
    • Trend critical quality attributes and process parameters
    • Establish alert and action limits
  • Consider Alternative Metrics
    • Measure quality culture
    • Cultivate quality through continuous improvement

Stay ahead of the curve!  Register today to understand the FDA’s vision for Quality Metrics and elevate and expand your existing programs with an array of data analysis solutions.

Who Will Benefit

  • VP Operations
  • Director Operations
  • VP Technical Operations
  • Director Technical Operations
  • VP Quality
  • Director Quality
  • Manager Quality
  • VP Manufacturing
  • Director Manufacturing
  • Manager Manufacturing
  • VP IT
  • Director IT
  • Manager IT

Sign Up for FREE Below

Meet Your Presenters

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Carmen Medina, MPH, PH.D.

Vice President, Technical Services, PAREXEL® CONSULTING

Carmen uses 28 years of FDA experience to support an array of US and international clients in their preparations for successful pre-approval inspections and FDA GMP inspections. She was a former Commissioned Officer in the United States Public Health Service and an FDA Investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations, QSR. Over the past 28 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands.

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Daniela Jansen, PH.D.

Director, Solution Marketing, Dassault Systèmes BIOVIA

Daniela is Director, Solution Marketing at BIOVIA and has more than 20 years of experience in laboratory informatics and instrumentation holding various positions in Marketing and Sales Management. She is working on the strategic product positioning and customer benefits of the BIOVIA Life Science solutions and has expertise in 21 CFR Part 11 Compliance and Lean Six Sigma.