GMP Training Systems

New Web Seminar

Cost Effective – Time Effective – In your Conference Room or Office

Avoiding Statistical Pitfalls during Method Validation

Conducted by Steven Walfish
President, Statistical Outsourcing Services

June 13, 2008

Would you like to know more about how to best analyze your data fro method validation?

Come learn how to avoid the Statistical Pitfalls!

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

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.

Avoiding Statistical Pitfalls during Method Validation

Register now!

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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 GMP080613E - CD and Handout materials Avoiding Statistical Pitfalls during Method Validation CD price includes all HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar

$397.00

Instructor

Steven Walfish - MS, MBA, President, Statistical Outsourcing Services

Mr. Steven Walfish brings two decades 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.

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