Root Cause Analysis for CAPA Investigations

Problem solving is critical to successfully maintaining and improving pharmaceutical and biotech processes. Processes are dynamic and as predicted by the 2nd law of thermodynamics will deteriorate over time if left alone. Federal Regulation Title 21 requires that an organization’s quality system include a process for Corrective and Preventive Action. Central to an effective CAPA system is the identification of root causes of problems. Systematic approaches for problem solutions have been called for but few have appeared. Problem and deviation solutions tend to be handled individually. The frequent result is root causes are not identified and the problems reoccur.  

Why You Should Attend:

A systematic approach based on process and systems thinking and the DMAIC problem solving and improvement framework is presented, discussed and illustrated. The focus is on getting to root cause and putting permanent fixes in place so that the problems do not occur again. The concepts and methods involved to meet these objectives are introduced and illustrated with pharmaceutical and biotech case studies and examples.

Learning Objectives:

• Understand the Strengths, Limitations and Tools of current Approaches to Root Cause Analysis
• Systematic Approach to Root Cause Analysis: What it is, Why it is Needed and How to Implement the Approach
• How to Sustain the Elimination of Root Cause and the Importance of Periodic Management Review
• Tips, Traps and guidelines for successful root cause analysis

Areas Covered in the Session :

• What is Root Cause Analysis?
• Current Approaches: Strengths, Limitations and Tools
• Systematic approach – Roadmap and Tools
• Use of Define, Measure, Analyze, Improve and Control (DMAIC) problem solving model
• Solving system failure problems
• Integrating Corrective Action and Prevention
• Sustaining the Elimination of Root Cause
• Importance of Periodic Management Review
• Systematic Approach for Deviation Reduction
• Tips, Traps and guidelines for successful root cause analysis

Who Should Attend:

Anyone engaged in problem solving will benefit from being exposed to the material and approaches presented in this webinar. This group includes:

• Production Departments
• Quality Assurance Departments
• Research and Development Departments
• Product Development Departments
• Lab Testing Personnel
• Biologists and Microbiologists
• Chemists and Chemical Engineers
• Process and Manufacturing Engineers
• Quality 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.