- November 12, 2020
10:00 AM - 11:00 AM ET
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.
- Introduction to CDER’s Office of Quality Surveillance
- Quality Management Maturity
- Goals of the pilot programs
- Foreign manufacturers of active pharmaceutical ingredients (APIs), including facilities manufacturing drug substance intermediates used to produce APIs.
- Domestic manufacturers of finished dosage forms (FDF).
Director, Office of Quality Surveillance (acting)
Office of Quality Surveillance (OQS) | Office of Pharmaceutical Quality (OPQ) | CDER | FDA
- 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
|QMM Webinar||pdf (663.03 KB)|