Statistical Methods for Assay Validation

Instructor: Steven Walfish
Product ID: 700114
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

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

Why Should You Attend:

ICH Q2A, the guidance document for method validation supports the use of statistical methods to reduce total testing and for the interpretation of results.Specific topics include method specificity, linearity, accuracy and precision. Advanced topics such as regression analysis and variance components will be explored as it relates to method validation.

Areas Covered in the seminar:

  • Requirements of ICH Q2A
  • Method Specificity
  • Linearity and Range of the Method
  • Accuracy and Precision
  • Regression Analysis
  • Variance Components
  • Detection and Quantification Limits

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Analytical Method Scientists
  • QC and QA personnel
  • Quality Auditors

Instructor Profile:

Mr. 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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