In August 2023 the FDA released a whitepaper — “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development” — spelling out its planned quality management assessment approach.
The QMM program encourages drugmakers to implement management practices that go beyond current good manufacturing practice (CGMP) requirements.
Gain expert insights into QMM with the Quality Management Maturity and Measurement for Drugmakers encore video recording, a package of key sessions from the GMP Quality Management vSummit, held in November 2023. The presenters — a senior FDA official, two pharma executives and a consulting expert in quality metrics — dig into the details of QMM and offer insights on how to implement a program that matches the FDA’s priorities.
This 134-minute encore recording includes the following presentations:
Quality Management Maturity and Measurement for Drugmakers
In this keynote address from the Summit, CDER’s Associate Director for Strategic Initiatives Theresa Mullin discusses the current state of quality management and its challenges. She also discusses international efforts to develop a global regulatory pharmaceutical quality management capability.
Quality Management Maturity – Pharmaceutical Principles and Priorities
Two Merck officials discuss what the FDA has defined as core QMM principles and components and provide an example of how Merck is setting up its own QMM programs to ensure proactive quality compliance and continuous improvement.
Quality Metrics – How Do You Measure Quality?
Understand the key performance indicators for a strong quality management system and what they can tell you about any gaps or problems in your system. This presentation, led by Pritesh Patel, president of PRP Consulting, considers the concept of measuring quality, as well as the metrics fit for that purpose.
In August 2023 the FDA released a whitepaper — “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development” — spelling out its planned quality management assessment approach.
The QMM program encourages drugmakers to implement management practices that go beyond current good manufacturing practice (CGMP) requirements.
Gain expert insights into QMM with the Quality Management Maturity and Measurement for Drugmakers encore video recording, a package of key sessions from the GMP Quality Management vSummit, held in November 2023. The presenters — a senior FDA official, two pharma executives and a consulting expert in quality metrics — dig into the details of QMM and offer insights on how to implement a program that matches the FDA’s priorities.
This 134-minute encore recording includes the following presentations:
Quality Management Maturity and Measurement for Drugmakers
In this keynote address from the Summit, CDER’s Associate Director for Strategic Initiatives Theresa Mullin discusses the current state of quality management and its challenges. She also discusses international efforts to develop a global regulatory pharmaceutical quality management capability.
Quality Management Maturity – Pharmaceutical Principles and Priorities
Two Merck officials discuss what the FDA has defined as core QMM principles and components and provide an example of how Merck is setting up its own QMM programs to ensure proactive quality compliance and continuous improvement.
Quality Metrics – How Do You Measure Quality?
What are the key performance indicators for a strong quality management system and what can they tell you about any gaps or problems your system may have? This presentation will discuss the concept of measuring quality as well as the types of metrics fit for that purpose.
In August 2023 the FDA released a whitepaper — “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development” — spelling out its planned quality management assessment approach.
The QMM program encourages drugmakers to implement management practices that go beyond current good manufacturing practice (CGMP) requirements.
Gain expert insights into QMM with the Quality Management Maturity and Measurement for Drugmakers encore video recording, a package of key sessions from the GMP Quality Management vSummit, held in November 2023. The presenters — a senior FDA official, two pharma executives and a consulting expert in quality metrics — dig into the details of QMM and offer insights on how to implement a program that matches the FDA’s priorities.
This 134-minute encore recording includes the following presentations:
Quality Management Maturity and Measurement for Drugmakers
In this keynote address from the Summit, CDER’s Associate Director for Strategic Initiatives Theresa Mullin discusses the current state of quality management and its challenges. She also discusses international efforts to develop a global regulatory pharmaceutical quality management capability.
Quality Management Maturity – Pharmaceutical Principles and Priorities
Two Merck officials discuss what the FDA has defined as core QMM principles and components and provide an example of how Merck is setting up its own QMM programs to ensure proactive quality compliance and continuous improvement.
Quality Metrics – How Do You Measure Quality?
What are the key performance indicators for a strong quality management system and what can they tell you about any gaps or problems your system may have? This presentation will discuss the concept of measuring quality as well as the types of metrics fit for that purpose.
Go beyond simple compliance — implement a world-class QMM program that achieves continuous improvement and an active quality culture.
Go beyond simple compliance — implement a world-class QMM program that achieves continuous improvement and an active quality culture.