Methods - Areas of Expertise

Books
Software
Courses
  • Validation Sampling Plans (1 day)
    • Effectiveness checks use one-time sampling plans to make confidence statements, the same as used in other validation/verification studies.
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  • Validation Sampling Plans
Books
Software
  • VarTran
    • Uses equations generated by DOEs to set specifications.  Interfaces with several DOE packages.
  • Simulator
    • Used in DOE training courses to generate data for DOEs.  Provides simulations of both products and processes.
Courses
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Related Methods
  • Spec Setting, Tolerance Analysis and Robust Design
Books
Software
Courses
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Related Methods
  • Validation Sampling Plans
Books
Software
Courses
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Related Methods
  • Validation Sampling Plans
Books
Software
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Related Methods
  • Normality Testing and Transformations
Books
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Courses
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Related Methods
  • Validation Sampling Plans
  • Manufacturing Sampling Plans
Books

Software
Courses
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Related Methods
  • Validation Sampling Plans
  • Normality Testing and Transformations
Books
Software
  • Requires Minitab
Courses
  • None
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Forum Questions and Answers
Related Methods
  • Validation Sampling Plans
Important Advances
Books
Software
Courses
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Related Methods
  • Design of Experiments
Books
  • Statistical Procedures for the Medical Device Industry
    • STAT-01 Statistical Policy
    • STAT-02 Glossary of Statistical Terms
    • One Sample Confidence Intervals
      • STAT-12  Verification/Validation Sampling Plans for Proportion Nonconforming
      • STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities
      • STAT-14 Verification/Validation Sampling Plans for Average
      • STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD
    • Two Sample Comparisons
      • STAT-16 Statistical Techniques for Equivalence Testing
    • STAT-19 Rounding of Data
  • Optimization and Variation Reduction in Quality
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Related Methods
  • Design of Experiments
  • Validation Sampling Plans
  • Normality Testing and transformations
Books
Software
  • Requires Minitab
Courses
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Forum Questions and Answers
Related Methods
  • Areas of Application Requiring Validated Test Methods
    • Design Validation (Clinical and User Testing)
    • Design Verification (Product Testing)
    • Process Validation (Process and Supplier Testing)
    • Manufacturing Sampling Plans
Important Advances
  • Change-Point Analysis is a powerful trending tool for detecting change, including multiple changes.  It is a great CAPA investigation tool, outperforming traditional control charts at detecting sustained shifts, and better describing the changes.
  • Normalized IN control charts allows I charts to be normalized based on volumes.  This makes it the preferred chart for complaint and other count data.  Average and IN charts may be the only 2 types of control charts you ever need.
Books
Software
Courses
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Related Methods
  • Test Method Validation
  • Normality Testing and Transformations
Books
  • Statistical Procedures for the Medical Device Industry
    • STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming
    • STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities
    • STAT-14 Verification/Validation Sampling Plans for Average
    • STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD
    • STAT-16 Statistical Techniques for Equivalence Testing
    • STAT-17 Statistical Techniques for Reliability Life Testing
    • STAT-18 Statistical Techniques for Normality Testing and Transformations
Software
Courses
Blog Articles
Forum Questions and Answers
Related Methods
  • Reliability Testing
  • Normality Testing and Transformations
  • Areas of Application
    • Audits and Effectiveness Checks
    • Design Validation (Clinical and User Testing)
    • Design Verification (Product Testing)
    • Process Validation (Process and Supplier Testing)
    • Test Method Validation