Using Statistical Methods to Design Method Validation

Conducted by Steven Walfish
President, Statistical Outsourcing Services

September 20, 2007

Would you like to know more about Statistical Methods used in Method Validation?

Come learn about this powerful and versatile technique!

This web seminar will present the basics of ICH Q2R(1) (International Conference on Harmonization – Validation of Analytical Procedures), utilization of statistics to reduce total testing, and interpretation of results.

The session will explain why using a sound statistical design can reduce total testing time, increase accuracy of results, and enhance your validation package.

Steven L. Walfish, a well-known consultant in statistical methods for biotech, pharmaceutical and medical device companies will conduct this seminar. He is a member of the Editorial Advisory Committee for Biopharm magazine, and has presented at numerous conferences on validation.

Specific areas that will be covered include:

  • Requirements of ICH Q2R(1)
  • Method Specificity
  • Linearity and Range of the Method
  • Accuracy and Precision
  • Regression Analysis
  • Variance Components
  • Detection and Quantification Limits

Lasting just one hour, you will be able to follow along on this web seminar with a PowerPoint presentation constructed specifically for this seminar. You will be able to submit oral or email questions to Mr. Walfish during and after the formal presentation.

By the end of the hour, you should have a better understanding of the ICH Q2R(1) standard and common statistical methods used to ensure a complete method validation. A detailed outline follows and Mr. Walfish's qualifications are below.

Using Statistical Methods to Design Method Validation

Part I

  • Basic review of ICH Q2R(1) guidelines
  • Quantification versus Limit Assay

Part II

  • Specificity of a method
  • T-test for comparing two samples

Part III

  • Linearity and range
  • Regression analysis

Part IV

  • Accuracy and precision
  • Tolerance intervals
  • Variance components

Part V

  • Detection and quantification limits

Part VI - Questions and Answers

  • Steven Walfish will field your questions live on the phone. You will hear all questions and answers from all participants of this teleseminar.

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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.

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Get the CD and handout
GMP070920E - CD and Handout materials
Using Statistical Methods to Design Method Validation
CD price includes HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar		 $397.00 Add to Cart

Steven Walfish
MS, MBA, President, Statistical Outsourcing Services

Mr. Steven Walfish 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. Human Genome Sciences (HGS) is a biopharmaceutical company specializing in the discovery and development of protein and antibody therapies for unmet medical needs. Mr. Walfish provides statistical methods for data collection, analysis and reporting. 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.