ComplianceOnline

Statistical Pitfalls During Method Validation

Instructor: Steven Walfish
Product ID: 700903
  • Duration: 60 Min

recorded version

$199.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$350.00
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This presentation will review issues that can arise during the data analysis of method validation protocols.

Description

Emphasis is on the impact of the pitfalls of using statistical methods ineffectively.

The ICH and USP guidelines for method validation do not specify statistical methods for data analysis. Using the inappropriate statistical method could lead to invalidate or incorrect conclusions. This presentation will review issues that can arise during the data analysis of method validation protocols. Emphasis is on the impact of the pitfalls of using statistical methods ineffectively.

Areas Covered in the seminar:

  • Basic Review of Q2R (1) including definitions used in method validation.
  • Selecting the Correct Statistical Method including ANOVA and regression analysis.
  • The Effect of Sample Size on the Analysis.

Who will benefit:

  • QC Managers
  • Development Scientist
  • Assay development personnel

Instructor Profile:

Steven Walfish, is the founder and President of Statistical Outsourcing Services. He brings over 17 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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