Presenter : Dr. Ronald D. Snee Duration : 3 Hours


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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

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