Statistical Concepts of Process Validation
Date & Time: Thursday, August 04, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 75 Minutes
Instructor: Dan OLeary
Price : $245.00
(for one participant)
Overview: Dan OLeary President, Ombu Enterprises
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management. ...more
Why you should attend: If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This is the essence of the statistical approach. This webinar presents the statistical approach that will help you validate your processes. Your team should attend this webinar if you cannot easily answer these questions. l
Can you give the statistical rational for you verification sampling plans? Can you state the desired and actual process capability you need to achieve? Can you list the worst-case input parameter combination for
your process? Do you know how to determine challenge points for your process?
Have you set action limits for your process inputs?
Areas Covered in the Session:
Suggest a Topic
Your Necessity is our Priority
QMS Requirements for Process Validation FDA’s QSR (21 CFR §820.75) ISO 13485:2003 The Statistical Process Model ¡ Relating input to output ¡ ¡
The Process Output ¡ Sampling Inspection ¡ Process Capability The Process Input Parameters
Design of Experiments The Challenge Points Risk Management
Production Information Validated Processes as High Risk
Click here to register for this webinar Who Will Benefit: l
Quality Engineers Production Managers Production Supervisors
Manufacturing Engineers Production Engineers Design Engineers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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Published on Jul 7, 2011
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer mus...