Process Validation Principles and Protocols for Medical Devices


    Live Webinar         on
     Process Validation Principles and Protocols for Medical Devices

     Course "Process Validation Principles and Protocols for Medical
     Devices" has been pre-approved by RAPS as eligible for up to
     1.00 credits towards a participant's RAC recertification upon
                                                                                                  Register Now                         

     full completion.

    Date & Time:                                                                            Instructor Profile:

     Thursday, May 31, 2012              10:00 AM PDT | 01:00 PM EDT
                                                                                                           Jeff Kasoff
     Duration: 60 Minutes                Instructor: Jeff Kasoff                                      Director of Regulatory
                                                                                                      Affairs, Life-Tech, Inc
     Location: Online                    Price : $245.00   (for one participant)

                                                                                            Jeff Kasoff, RAC, is the Director of
                                                                                            Quality at Byrne Medical, a leading
    Overview:                                                                               manufacturer of endoscopy and
    The benefit of a consistent process is that the yield meets expected                    colonoscopy devices, where he
    criteria. Firms that are able to implement such processes minimize                      oversees the operation of the quality
    their process rejections and therefore maximize profit.                                 system. In this position, Jeff is
                                                                                            responsible for oversight of the
                                                                                            document control system, including
    Domestic and international regulations actually assist in this
                                                                                            maintenance of regulatory
    endeavor, by setting forth the requirements to assure a process is                      documentation. Prior to this, Jeff
    consistent, and that it yields output that is both safe and effective.                  spent 13 years at Life-Tech, Inc. as
    These requirements are applicable to both automated and manual                          the Director of Regulatory Affairs,
    processes. This webinar explains the regulatory requirements for                        where he was responsible for
    process validation, and also includes definitions and application of                    compliance of the corporate quality
    applicable terminology, and hints and recommendation for the more                       system. Jeff received his regulatory
                                                                                            affairs certification in 1996. ...more
    common types of process validation. Also covered will be the                    
    validation technique used for processes that are already in place.

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    Areas Covered in the Session:
                                                                                             Your Necessity is our Priority
       l   What is Validation?
       l   When should it be used?
       l   How does it differ from verification?
       l   Validation vs. Verification: Which One?
       l   Protocol preparation                                                                                
       l   Different types of validation
       l   IQ, OQ, and PQ

    Click here to register for this webinar

    Who Will Benefit:

       l   Validation Specialists/Managers
       l   Process Engineers
       l   Manufacturing Engineers
       l   Quality Engineers
       l   Product/Process Development personnel
       l   Research and Development personnel
       l   Quality/Regulatory Personnel

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,

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Description: The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.