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

Wednesday, November 6, 2024 - 12:00am to 2:00pm EST

Jason Kerr – Sr. Manager, Regulatory Intelligence and External Engagement, Moderna

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.

While the agency has completed some pilot programs focusing on API and Finished Dosage Form (FDF) manufacturers, it is anticipated that the agency will eventually expand the scope of these assessments to include all essential suppliers involved in the life cycle of medicinal products, including excipients.

In this webinar the presenter will embark on a transformative journey with the FDA's QMM assessment, an initiative that promises to revolutionize pharmaceutical standards. Join Jason Kerr on unraveling the impact of QMM and its potential to impact the excipient community, as it becomes part of the regulatory framework.

Learning/Awareness Objectives

Attendees will be provided with:
> A general history of QMM and its evolution to its current state today
> An evaluation of the current challenges of implementing QMM
> A scenario for how excipient manufacturers may incorporate QMM into their quality system.

Who should attend?
> Pharmaceutical formulators and development scientists
> Excipient manufacturers
> Regulatory affairs and legal professionals
> Safety evaluation professionals
> Compendial affairs
> Quality affairs

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Note: Did you know this webinar may count toward continuing education credits? Check with your credentialing organization to confirm. A certificate of participation will be available for download upon completion of the webinar.