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To ensure an organization’s quality system has a system to identify product and quality issues; the FDA mandates establishing a process for Corrective and Preventive Action. Any effective CAPA system must include the identification, documentation and review of root causes of problems. Systematic approaches for problem solutions need not only identify but also validate the effectiveness of a CAPA action. If both problem and deviation solutions handled individually; the frequent result is root causes are not identified and the problems reoccur. If you want to successfully maintain and improve pharmaceutical and biotech processes problem solving is a critical necessity. CAPA must be part of the company’s comprehensive quality management system (QMS). Processes are dynamic and as predicted by the 2nd law of thermodynamics will deteriorate over time if left alone.

Why You Should Attend:

This webinar will be presented with the goal to leave our attendees with a systematic approach based on process and systems thinking. This session will also illustrate and discuss how the DMAIC problem solving methodology could create a more effective and efficient process. The focus will be on creating long lasting solutions in place so that problem areas identified by root cause analysis do not occur again. Case studies and examples from the pharmaceutical and biotech industry will be introduced to demonstrate how the concepts and methods will help meet the objectives.

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.