Recently the FDA released their draft Guidance for Industry entitled “Request for Quality Metrics”. Much discussion of quality metrics has ensued regarding this guidance and its elements. This presentation provides an integrated view of the aspects of Quality Metrics including the required supporting quality culture.
This presentation will deepen your knowledge of Quality Metrics including the challenges, how to identify the challenges and how to overcome the challenges. The aspects of quality metrics and the building blocks of measurement systems are also addressed. Tips, traps and recommendation on startup are included. This knowledge will enable the speedy implementation of a quality metrics system.
- What are the Challenges?
- Myths of measurement
- What to measure? How to Measure?
- Dealing with resistance
- Uncovering the Challenges
- Review of metrics to identify opportunities for improvement
- Reviewing actions taken
- Assessing measurement and data quality
- Building Blocks of Measurement Systems
- Pyramid of measurement
- Holistic measurement system
- Analysis and reporting
- Tips, Traps and Getting Started
- Continually improving measurement systems
- Research & Development Departments
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Financial Analysts
- All professionals who collect, analyze and report quality metrics to the FDA and who present data to solve problems and make improvements