21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits by globalcompliancepane


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    2-day In-person Seminar on
     Statistics for Quality Control and Assurance

     Course "Statistics for Quality Control and Assurance" has been
     pre-approved by RAPS as eligible for up to 12 credits towards a
     participant's RAC recertification upon full completion.
                                                                                             Register Now                         

    Date & Time:
                                                                                        Instructor Profile:
     September 27th and 28th 2012          8 AM to 5 PM EDT

                                           Instructor: Steven S                                   Steven S Kuwahara
     Duration: 2 Days
                                           Kuwahara                                              Founder & Principal, GXP
                                                                                                    Biotechnology, LLC
                                           Price : $1,295.00   (for one
     Location: Courtyard New Jersey
                                                                                        Steven S. Kuwahara, Ph.D. is the
             Register for 4 Participants to Get 1 Free Pass                             founder and Principal of GXP
                                                                                        BioTechnology LLC, a consulting firm
                                                                                        that works in the areas covered by
    Overview:                                                                           the GLP and GMP of drugs, biologics,
                                                                                        and nutraceuticals. Steve has over
    This course will describe the use and application of simple, basic                  30 years of experience in
    statistical procedures, especially as they can be applied to the types              supervising quality control
    of studies needed in the field of pharmaceutical quality systems. The               laboratories, including an animal
    course will focus on the use of statistical functions for the execution             testing facility, and in performing
    of validation studies, the setting of specifications and the on-going               GLP and GMP audits of internal and
    monitoring of manufacturing processes and analytical methods.                       external testing laboratories . Steve
                                                                                        has participated in the development
    Attention will also be given to checking employee performance and
                                                                                        of drugs and biologicals through all
    comparing actual test results to expected values.
                                                                                        phases of clinical research and final
                                                                                        product production. ...more
    The course will not require the use of any particular software or a
    computer. It is presented with a paper-and-pen approach so the
    attendee can understand that processes that must occur for the
                                                                                       Suggest a Topic       More Webinars
    calculations to be made in a software package.
                                                                                         Your Necessity is our Priority
    Course Outline:
    Day 1, September 27, 2012

    Course Modules & Content Details:
    Lecture 1: Introduction to Process Statistics

       l   Averages and variability
              ¡ Standard deviations and the standard error of the

       l   Setting specifications using intervals
               ¡ Confidence and tolerance intervals

    Lecture 2: Comparing two sets of data.

       l   t-Tests and the deviation about a mean.
       l   Demonstrating that specifications are met.
       l   Comparing deviations.
       l   Sampling and replicates

    Lecture 3: Comparing multiple sets of data.
       l   One-way and two-way analysis of variance.
       l   Duncan's multiple range test.
       l   Latin square designs
       l   Factorial designs

    Lecture 4: Regression analysis

       l   Linear regression
       l   Linear correlation analysis

    Day 2, September 28, 2012

    Lecture 5: Screening methods and Factorial designs.
     l   Plackett-Burman Method.
            ¡   Studying an analytical method.
            ¡   Process design study
            ¡   Importance of confounding.

 Lecture 6: Monitoring Methods and Processes

     l   Process Capability Indicies
     l   Statistical Process Control for variable data.
             ¡ The Western Electric rules.

 Lecture 7: Statistical Process Control for attribute data.

     l   Dealing with counts.
     l   CUSUM charts for single points.

 Lecture 8: Other Procedures

     l   Non-parametric tests when a normal distribution cannot be
            ¡ The Wilcoxon Signed Rank Test.

     l   The Poisson Distribution for infrequent events.
     l   The Spearman-Karber Method for estimating counts.

 Click here to register for this seminar

  Who Will Benefit:

     l   Directors
     l   Managers
     l   Supervisors, and Lead Workers in Quality Control
     l   Quality Assurance
     l   Engineering, and Regulatory Affairs
     l   Workers who will be participating in operations or the
         supervision of the development or manufacturing of
         pharmaceuticals should also attend this course.

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,

About GlobalCompliancePanel
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