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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

Location: Online

Price : $245.00

 

  

Register Now

(for one participant)

Instructor Profile:

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

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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

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your process? Do you know how to determine challenge points for your process?

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Have you set action limits for your process inputs?

Areas Covered in the Session:

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QMS Requirements for Process Validation FDA’s QSR (21 CFR §820.75) ISO 13485:2003 The Statistical Process Model ¡ Relating input to output ¡ ¡

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The Process Output ¡ Sampling Inspection ¡ Process Capability The Process Input Parameters

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Design of Experiments The Challenge Points Risk Management

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Production Information Validated Processes as High Risk

Click here to register for this webinar Who Will Benefit: l

Quality Managers

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Quality Engineers Production Managers Production Supervisors

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Manufacturing Engineers Production Engineers Design Engineers

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Process Owners

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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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe


Statistical Concepts of Process Validation