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.
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.
