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?
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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.
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.