Effective Root Cause Analysis: The key to an effective corrective actions system
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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. 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: 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. 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.Â
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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. Learn how Root cause analysis can be used in process control.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works •
Username and Password will be sent to you 24 hours prior to the webinar
•
Presentation handouts in pdf formate will be mailed to you
•
Login to the session using the username and password provided to you
•
Get answer to your queries through interactive Q&A sessions via chat
•
Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
•
Get certification of attendance.
Recorded Session - How it works •
A link will be provided to you upon purchase of the recorded session
•
Please click on the link to access the session
•
Presentation handouts in pdf formate will be mailed to you
•
Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Get Connected :
www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com