Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Attribute Data

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					                                                                        Toll Free Number: 800-447-9407


                                                                                        Live Webinar on


Statistics for Quality Control and Process Validation: Statistical Process
Control (SPC) for Attribute Data

Date: Wednesday, March 6, 2013                                           Time: 12:30 PM PST | 03:30 PM EST

Course "Statistics for Quality Control and Process
Validation: Statistical Process Control (SPC) for              Duration:       90 Minutes
Attribute Data" has been pre-approved by RAPS as               Instructor:     Steven S Kuwahara
eligible for up to 1.5 credits towards a participant's         Location:       Online
RAC recertification upon full completion.


                    Steven S Kuwahara
                    Founder & Principal, GXP                                 Register Now
                    Biotechnology, LLC

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that
works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30
years of experience in supervising quality control laboratories,   ...more

Overview:
Once a test method or manufacturing process has been validated there is a continuing need to
demonstrate that the procedure continues to operate in a manner that meets the validation
requirements.


The recent guidance document on process validation has indicated that the Food and Drug
Administration is expecting to see continuous process verification employed over the working life of
a test method or manufacturing process. Statistical Process Control (SPC) charting has long been
recognized as a method for monitoring processes of all types. This webinar will discuss the
application of SPC to attribute data, and present the rules used in the interpretation of the charts.

Areas covered in the session:

    l   SPC charts based on simple counts of attributes.
        Conversion into a variables chart.
    l   Binomial Data and Distribution
    l   SPC chart for binomial data
    l   SPC chart for counts following the Poisson
        Distribution



Who Will Benefit:

    l   Regulatory Affairs
        personnel who prepare
        the CMC sections of               Suggest a Topic
        submissions.
    l   Development personnel              More Webinars
        who will set the early
        specifications.
    l   R & D personnel who will
        contribute data for use in
        development.                      Click here to
    l   Project managers for            register for this
        product development                  webinar
        studies.
    l   Quality systems auditors
    l   Consultants.



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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www.globalcompliancepanel.com
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CA 94539, USA

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DOCUMENT INFO
Description: Once a test method or manufacturing process has been validated there is a continuing need to demonstrate that the procedure continues to operate in a manner that meets the validation requirements. The recent guidance document on process validation has indicated that the Food and Drug Administration is expecting to see continuous process verification employed over the working life of a test method or manufacturing process. Statistical Process Control (SPC) charting has long been recognized as a method for monitoring processes of all types. This webinar will discuss the application of SPC to attribute data, and present the rules used in the interpretation of the charts.