Improving Process Stability and Capability – Tips, Traps and Guidance

FDA’s Process Validation Guidance Stage 3 calls for “ongoing assurance is gained through routine production that the process remains in a state of control.” Two critical considerations in assessing process behavior are process stability and capability. Tools commonly used to demonstrate that a process is in a state of control include: control charts, process capability indices, analysis of variance and graphics. Unexpected problems are often encountered when using these tools. In this session “tips and traps” are discussed that enable pharmaceutical scientists and engineers to develop effective process monitoring systems and avoid commonly encountered problems and pitfalls.

The issues discussed include: how to reduce false out of control signals, measures of process stability, how to identify causes of out of control signals, how to select the appropriate sampling procedures. The approaches and tools discussed are illustrated with pharmaceutical and biotech case studies and examples.

Areas Covered in the Session :

• Reducing False Out of Control Signals
• How to Use Process Stability Metrics
• Selecting Appropriate Sampling Procedures
• Identifying Causes of Out-of-Control Signals – The Usual Suspects
• Early Warning Devices for Detecting Process Shifts
• How to Select the Right Control Chart
• Can We Reduce Sampling
• Assessing the Pedigree of Your Data
• Tips, Traps and Guidance – What to Watch Out For

Who Should Attend:

• Production Managers
• Process and Manufacturing Engineers
• Quality Assurance Managers, Scientists and Engineers
• Quality Engineers
• Lab Testing Personnel
• Research and Development Scientists
• Product Development Personnel
• Biologists and Microbiologists
• Chemists and Chemical Engineers
• Supply Chain Professionals
• Process Improvement Professionals

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.