Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be used by FDA: to help and develop compliance and inspection policies and practices, such as risk- based inspection scheduling of drug manufacturers; to improve the agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state –of –the- art, innovative quality management systems for pharmaceutical manufacturing.

_{^{Who Should Attend}}

• Quality Heads
• Quality Group Leaders, Managers
• Quality Control Heads
• Quality Control Leaders, Managers
• Production Heads
• Production Leaders, Managers
• Technical Managers, Engineering Managers

_^Outlines

• Data vs Knowledge
• Quality Objectives
• Metrics and Measurement
• KPIs
• Predictive Metrics
• Reactive Metrics
• Risk Management
• CAPA
• Product versus Process
• Process Parameters versus Quality Attributed
• Data Collection Plans
• Use of checklists and graphs
• Quality Culture and Metrics
• Metrics and changing the culture
• Company to company
• Bad metrics