Effective Root Cause Analysis : The key to an effective corrective actions system

Duration: 60 Minutes
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. We will cover where else in your quality management system it can be used, and describe some of the techniques for effective root cause analysis. Examples will be cited to illustrate how each technique works.
Root Cause Analysis Training
Instructor: Betty Lane
Product ID: 500653

Corrective Actions are one of the top areas of FDA 483 citations from audits they perform at medical device manufacturers. The FDA once shut down almost all the diagnostic manufacturing of a company that consistently failed to implement an effective corrective action system. To have an effective corrective action system, you must do a good job of understanding the root cause of the problem you are dealing with. This seminar will give you tips on some of the best and most effective ways to do root-cause analysis.

Why Should you Attend:
Is your Corrective action system effective or do the same or similar problems keep occurring? If so, you may not be doing root cause analysis in sufficient depth. Corrective and Preventive actions (CAPA) are key to an effective quality management system. The key to an effective CAPA system is knowing how to do an in-depth root cause analysis. Learn various techniques that are available, so you can choose the one or ones that fit your situation. Learn how Root cause analysis can be used in process control.

Objectives of the Presentation:
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. We will cover where else in your quality management system it can be used, and describe some of the techniques for effective root cause analysis.

We will cover:
  • What is Root Cause
  • The difference between Correction, Corrective Action and Preventive Action
  • Why Root Cause Analysis is important
  • Where Root cause Analysis is valuable
    • Corrective and Preventive Action
    • Risk Management
    • Process Control
  • Techniques for Root Cause Analysis
Who can Benefit:
This presentation will benefit all those involved with internal or supplier corrective actions. If you issue corrective actions, you need to know what an effective root-cause analysis looks like. If you are assigned to complete a corrective action, you need to know what is expected for a root-cause analysis. If you manage the corrective action system or those doing corrective actions, it is also important that you understand root-cause analysis. So that means almost anyone working within a medical device quality system could benefit from understanding the how and why of root-cause analysis.

This webinar will provide valuable assistance to all personnel in:
  • Quality Management
  • Quality Engineers
  • Manufacturing Engineers
  • Internal auditors
  • Quality specialists
  • Quality Associates
  • Operations and Manufacturing Managers
  • Process Engineers
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
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