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This webinar was recorded on November 12, 2020.

Through this pilot program, a third-party contractor identified by the FDA will conduct an onsite assessment of a facility’s quality management system, accompanied by FDA staff.  The Agency will gain insight from the results of the Quality Management Maturity (QMM) assessments to inform the development of a framework for conducting QMM assessments of manufacturers and a rating system that will incentivize industry investments in quality management maturity.

Participation is voluntary and the participating sites will be able to use assessment information in their continual improvement efforts.

TOPICS COVERED

• Introduction to CDER’s Office of Quality Surveillance
• Quality Management Maturity
• Goals of the pilot programs

INTENDED AUDIENCE

• Foreign manufacturers of active pharmaceutical ingredients (APIs), including facilities manufacturing drug substance intermediates used to produce APIs.
• Domestic manufacturers of finished dosage forms (FDF).

FDA SPEAKERS

Jennifer Maguire
Director, Office of Quality Surveillance (acting)
Office of Quality Surveillance (OQS) | Office of Pharmaceutical Quality (OPQ) | CDER | FDA

FDA RESOURCES

• Federal Register Notice: Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement
• Federal Register Notice: Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement

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