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Advanced Methods of Root Causes Analysis for ISO 14971 Risk Reduction

Date: 01-Mar-12 to 01-Mar-12
Location: OnlineWebinar / California City / United States
Category: Healthcare & Pharmaceuticals

This 90-minute webinar on Advanced Methods of Root Causes Analysis, for medical device companies, will cover principles and methods of Root Cause Analysis (RCA) and review proven techniques for ISO 14971 Risk Reduction based on RCA.
Root Cause Analysis (RCA) is the most important tool in device recall investigations and for preventing the adverse events. Unfortunately there is substantial misunderstanding of the limitations of the tool and how to use it correctly. The result is often wrong judgments, wrong design changes, and wasted efforts. Doing it right will reduce costs. Using advanced methods will make a big difference in preventing recalls.
Areas Covered in the Seminar:

* Principles of Root Cause Analysis (RCA).
* FDA Quality System Requirements for RCA.
* RCA from the point of view of the system.
* Root Cause Analysis methods.
* Role of RCA in Failure Mode and Effects Analysis.
* Using Fault Tree Analysis as RCA tool.
* Risk analysis based on RCA.
* Risk reduction based on RCA.

Visitors

* Design engineers
* Product Management
* Production management
* Safety
* Regulatory
* Purchasing & Production
* Quality Assurance staff
* Suppliers

Exhibitors

At ComplianceOnline, we are focused on :
Enhancing global compliance, creating a world where quality and compliance professionals, regulators,and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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