online webinar 2019 - Root Cause Analysis for CAPA Investigations A Systematic Approach Live Webinar

Overview
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.
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.
Session Highlights
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
Learning Objectives
• Understand the Strengths, Limitations and Tools of current Approaches to Root Cause Analysis
• Systematic Approach to Root Cause Analysis:
o What it is, Why it is Needed and How to Implement the Approach
• How to Sustain the Elimination of Root Cause and the
o Importance of Periodic Management Review
• Tips, Traps and guidelines for successful root cause analysis
Who Will Benefit
Production Managers
Quality Assurance Managers, Scientists and Engineers
Research and Development Scientists
Product Development Personnel
Lab Testing Personnel
Biologists and Microbiologists
Chemists and Chemical Engineers
Process and Manufacturing Engineers
Quality Engineers
Supply Chain Professionals
Process Improvement Professionals
Speaker
Ron Snee is Founder and President of Snee Associates, LLC, a firm dedicated to 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 approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Schering Plough, Human Genome Sciences, Boehringer-Ingelheim and Kraft Foods. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical clinical trial design and analysis. He has developed and applied process design, improvement, monitoring and control methodologies for more than 30 years.
His recent application and research on QbD has produced eight 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. Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.
Ron is an Honorary Member of the American Society for Quality and has been awarded ASQ’s Shewhart, Grant and Distinguished Service Medals. The American Statistical Association has recognized his contributions with ASA’s Deming Lecture, Dixon Award and Hahn Quality and Productivity Achievement Awards. He is an academician in the International Academy for Quality and Fellow of the ASQ, ASA, and American Association for the Advancement of Science. He is a frequent speaker and has published 7 books and more than 330 papers in the fields of performance improvement, quality, management, and statistics. He is a recipient of the Institute of Validation Technology Speaker of the Year Award