In July 2015 the FDA released their draft Guidance for Industry entitled “Request for Quality Metrics”.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.
Areas Covered in the Session :
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
Who Will Benefit:
Research & Development Deparments
Quality Assurance Deparments
Quality Control Deparments
Regulatory Affairs Deparments
All professionals who collect, analyze and report quality metrics to the FDA and who present data to solve problems and make improvements