Data-Based Process Monitoring,
Control and Improvement
A Systematic Approach

Process monitoring, control and improvement has been at the heart of quality management for decades. The methodology continues to develop and has moved into a new era with the widespread availability of online data collection systems. This development creates the need for better utilization of the collected data for process monitoring, control and improvement.

This presentation discusses some recent advances. The FDA’s 2011 Process Validation Guidance calls for “Continued Process Verification” (CPV). Process monitoring provides the tools for enabling CPV and dealing with variation. Managing and reducing variation is at the heart of the FDA Process Validation Guidance. Clearly stated in the guidance is the need to understand variation, ability to detect variation, understand the impact of variation and ability to control variation.

This session addresses the concepts, methods and tools used in process monitoring, control and improvement and in turn continued process verification. It is shown how the tools are integrated to create a DATA-BASED SYSTEM that links process monitoring, control and improvement. This system enhances the use of the tools and the effectiveness of continued process monitoring, control and improvement. The approach is illustrated with a variety of case studies including pharmaceuticals.

Top Ten Benefits – What the Attendees will Learn

  1. Implementation of FDA Validation Guidance regarding Continued Process Verification (CPV)
  2. Tools for assessing process control and capability
  3. How to reduce process risk
  4. How to reduce test method Risk
  5. How to integrate statistical tools into a system for process monitoring, control and improvement (CPV)
  6. How to identify and reduce “special causes” of variation
  7. Common sources (“The usual suspects”) of process problems
  8. Role of management in process monitoring, control and improvement
  9. Process Control Strategy – Integrating use of process Stability and Capability Metrics
  10. Tips and traps – What to watch out for


Ronald D. Snee, Ph.D

Founder And President, Snee Associates, LLC

Ron Snee is Founder of Snee Associates, LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives, using Quality by Design, Lean Six Sigma and other improvement approaches. He is also an Adjunct Professor in the RAQA and pharmaceutical programs at Temple and Rutgers Universities. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceutical development. He has published eight books and more than 330 articles, 60 of which has appeared in the pharma and biotech literature. He is an Honorary Member of the American Society for Quality and has received numerous honors and awards for his research, consulting and publications.