Duration: 90 Minutes


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In July 2015 the FDA released their draft Guidance for Industry entitled “Request for Quality Metrics”.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 Should Attend:

  • 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

Course Director: DR. RONALD D. SNEE

Ronald D. Snee, PhD, is Founder and President of Snee Associates, LLC. He provides guidance to senior executives in their pursuit of improved business performance using Lean Six Sigma, Quality by Design (QbD), and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Human Genome Sciences, and Kraft Foods.

Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals.

He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.

Ron in an Honorary Member of the American Society for Quality and has been awarded the ASQ’s Shewhart, Grant and Distinguished Service Medals. Other awards and honors include the American Statistical Association’s Deming Lecture, W. J. Dixon Statistical Consulting Excellence and Gerald J. Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published six books and more than 300 papers in the fields of performance improvement, quality, management, and statistics.

He is a past recipient of the Institute of Validation’s Speaker of the Year Award.