Risk assessment and risk mitigation are topics of keen interest to medical device companies as well as governing agencies. How will you appraise risk? What actions will you take to reduce risk? How will you document the logic and activities? These are key themes currently being discussed at industry seminars by FDA representatives.
Failure Mode, Effects, and Criticality Analysis (FMECA) is a leading and recognized tool for medical device companies to use for the above activities. FMECA is a rigorous "bottoms-up" approach that is equally applicable to products, processes and services. Effective application of FMECA is essential to business success. Complete at too high a level and you may well gloss over essential topics. Complete at too low a level and the approach can lead to bureaucratic dysfunction.
Learn how your cross-functional team can use this important tool to assess, quantify and prioritize actions to mitigate risk.
Cost: $399.00
Length: 4 Hours
Click on the "Add to Cart" button or call 1-719-282-1143 to register for this webinar.
Click on the tabs below for more information.
Agenda
Brief introductions
Goals of session
What is FMECA?
What are the benefits to using FMECA in your validation efforts?
What is the thought process?
How to maximize organizational benefit
Steps in successful application
Planning for Success: Team make-up, required pre-work
Examples from medical device industry
Linking functional analysis
Determination of risk (RPN)
Prioritization of actions based upon risk.
Actions to take
Documenting actions and follow-up activities
When to revise your documents
Summary
Trainer
Robert Launsby has taught hundreds of students Process Validation techniques. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.
Dates
The dates and locations are listed below:
Date
Start Time
September 2, 2011
8:00 am MST
November 8, 2011
1:00 pm MST
January 19, 2012
8:00 am MST
Cost
Fees: $399 includes the eBookProcess Validation for Business Success.
Guarantee
Launsby Consulting webinars and products are fully guaranteed. If any of our webinars do not meet your needs, contact us and we will promptly send you a refund. If any of our products fail to meet the highest standards of quality and performance, please return them in like-new condition in their original packing materials, and we will send you a refund.
Who Should Attend?
Professionals directly involved in the development and manufacturing of medical devices and meeting the FDA's quality system requirements. Individuals associated with regulatory affairs, quality assurance, process development or manufacturing will find this informative webinar extremely valuable.
Register Early - class sizes are limited for optimal interaction and instruction.
Call 1-719-282-1143 or click on the "Add to Cart" button above to Register.
If you have any questions, please feel free to email us at
or
call us at 1-719-282-1143.
Risk assessment and risk mitigation are topics of keen interest to medical device companies as well as governing agencies. How will you appraise risk? What actions will you take to reduce risk? How will you document the logic and activities? These are key themes currently being discussed at industry seminars by FDA representatives.