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Overview

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 illustrated with pharmaceutical and biotech case studies and examples. The systems approach provides a mechanism for implementation and sustaining of problem solutions and methodology over the long term.

Why you should Attend

This webinar provides some practical and useful answers to the question: 

How Do I Conduct Root Cause Analysis and CAPA Problem Solving Studies that Produce Long-Term Sustainable Solutions?

  • What the FDA is looking for in the use of root cause analysis, CAPA and problem solving
  • Mistakes pharma and biotech companies frequently make in root cause analysis and CAPA ods
  • Most frequently used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc.
  • What works and what doesn’t work
  • Information and ideas on approaches that have worked in a variety of situations
  • Problems to be on the lookout for and useful solutions
  • What are the most useful graphical and data visualization methods

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 framework
  • Integrating Corrective and Preventive Action
  • CAPA System - Mistakes, Issues and Management Review Importance
  • Finding Root Causes - Tips and Traps
  • Making Use of Data - Data Quality and Data Pedigree
  • What Statistical Tools Should I Use
  • Summary and Conclusions

Who Will Benefit

  • Regulatory Affairs Personnel
  • Department Managers
  • Quality Assurance Personnel
  • Quality Engineers
  • Process and Manufacturing Engineers
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Supply Chain Professionals

Speaker Profile

Ronald D.Snee is Founder and President of Snee Associates, a firm dedicated to the 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, Continued Process Verification, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical development.

He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 3 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 and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science.

He is an Honorary Member of ASQ and has been awarded ASQ’s Shewhart, Grant and Distinguished service Medals, and ASA’s Deming Lecture, W. J. Dixon Consulting and Gerry Hahn Quality and Productivity Achievement Awards. 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 past recipient of the Institute of Validation Technology Speaker of the Year Award.