Calculating Sample Size to Satisfy FDA Expectations
Do you struggle to identify the best sample size for your pharmaceutical or medical device products? Are you confident that your statistical methods and data can stand up to scrutiny during an FDA inspection?
Calculating Sample Size to Satisfy FDA Expectations will help you identify appropriate sample sizes for your products and generate the data needed to satisfy the regulators.
This management report explains how to best demonstrate that your facility’s approach to sampling is statistically sound and clarifies the relationship between risk management and sample size determination throughout your product’s life cycle.
- Understand how to use sample size calculations for verification and validation
- Know the assumptions and risks associated with calculating sample sizes
- Comprehend common mathematical formulas used for calculating sample sizes
- Learn why standards, such as ANSI Z1.4, should not be used for validation activities
Regulatory authorities require risk-based sample sizes that have a sound statistical foundation. Ensure your organization can meet their expectations with Calculating Sample Size to Satisfy FDA Expectations.
About the Contributor
Steven Walfish, president, Statistical Outsourcing Services, has more than 35 years of industrial experience in the development and application of statistical methods for solving complex business issues. He is an expert in the application of statistical methods to sample size determination, analytical method verification and validation, and stability analysis.
Who Will Benefit
- Quality assurance and quality control managers and staff
- Regulatory affairs managers and staff
- Document managers and staff
- Laboratory managers and staff
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