Implementing a Metrics Program – Uncovering and Overcoming the Challenges

Recently the FDA released their draft Guidance for Industry entitled “Request for Quality Metrics”.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.

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 Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Scientists
  • Engineers
  • Financial Analysts
  • All professionals who collect, analyze and report quality metrics to the FDA and who present data to solve problems and make improvements


Dr. Ronald D. Snee

Ronald D. Snee, PhD, is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture and W.J.Dixon Consulting Awards as well as numerous other awards and honors. He is a frequent speaker and has published 5 books and more than 255 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.

Featured Webinars :

Design of Experiments for Non-Statisticians
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Understanding and Implementing a Quality by Design (QbD) Program
Process Verification and Validation



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  • Presentation Handout in .pdf format
  • Certificate of Attendance