Root Cause Analysis for CAPA Investigations A Systematic Approach

01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Ron Snee is Founder and President of Snee Associates, LLC, a firm dedicated to successful implementation of process and organizational improvement initiatives"

A systematic approach based on process and systems thinking


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.

Areas Covered

•     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: 
•     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

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

Industries who can attend

This 90 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Ron Snee

Ron Snee is the Founder and President of Snee Associates, 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 is a frequent speaker and has published 5 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 Technology Speaker of the Year Award.

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