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John Smith

Webinar on Proactive Internal Auditing-The Key to Establishing, Maintaining, and Improv... - 0 views

This webinar provides a broad overview of the internal auditing functions starting with the concept of quality systems and their objectives, primarily using graphical methods. The webinar focuses o...

Proactive internal auditing functions fda audits ich q10 quality system Pharmaceutical Good Manufacturing Practices cGMP inspections Regulatory Affairs trends audit objectives of report life-cycle

started by John Smith on 01 Aug 14 no follow-up yet
John Smith

Webinar On Statistical Analysis of Gages - 0 views

compliancetrainings.com/...ProductDetailView.aspx

Statistical Analysis Gages Gage Correlation Linearity Bias R&R metrology vocabulary concepts guard-banded specifications Spreadsheets compliance trainings FDA

shared by John Smith on 17 Sep 14 - No Cached
  • John Smith on 17 Sep 14
     
    The seminar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias. The seminar ends with an explanation of how to combine all relevant uncertainty information into an "Uncertainty Budget" that helps determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications"). Spreadsheets are used to demonstrate how to perform the methods described during the seminar.
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