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Understanding the Foundation of Quality Management Maturity and its Potential Impact to the Excipient Community

Description

In response to the persistent challenge of drug shortages, the U.S. Food and Drug Administration (FDA) published a detailed report in 2019, "Drug Shortages: Root Causes and Potential Solutions." One proposed recommendation is the creation of a Quality Management Maturity (QMM) rating system to provide manufacturers with a standardized benchmark, enabling them to assess and compare the quality management practices with their peers.

Contributors

  • Jason Kerr

    Sr. Manager, Regulatory Intelligence and External Engagement
    Moderna

    Jason Kerr is an experienced quality and regulatory professional and has been a champion in engaging, connecting, and promoting regulatory compliance in the dynamic biopharmaceutical landscape. At Moderna, Jason strives to ensure regulatory compliance by monitoring the regulatory landscape and engaging with external stakeholders on hot topics. Jason holds a Bachelor of Science (BS) in Biochemistry from UCLA, a Master of Business and Science (MBS) from the Keck Graduate Institute (KGI), a Master of Business Administration (MBA) from the Quantic School of Business and Technology and holds a certificate in Bioscience Industry Law and Practice from Southwestern Law School. Jason is also an adjunct professor teaching regulatory affairs and quality systems at KGI.

November 6, 2024
Wed 12:00 PM EST

Duration 2H 0M

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