Calculating Sample Size to Satisfy FDA Expectations – Webinar Recording/Transcript
The FDA is increasingly focused on manufacturers’ use of sound statistical methods to determine sample sizes for verification and validation activities; an increase in the number of 483s and warning letters citing inadequate sampling bears that out. The lesson to be learned: drug and devicemakers need to devote more resources to developing statistical determination systems that can close the compliance gap.
Find out how to apply that lesson to your own sampling programs with this FDAnews presentation led by Steven Walfish, an expert with more than three decades of industrial experience in the development and application of statistical methods.
Walfish, president of Statistical Outsourcing Services, offers real-world examples of the assumptions and risks associated with calculating sample sizes in drug, device and combination product design. He explains the FDA’s expectations and outline best practices for using statistical methods.
Other Presentation Takeaways:
- Develop a clear understanding of how to implement sound statistical methods in verification and validation activities.
- Understand why specific standards, such as ANSI Z1.4, Sampling Procedures and Tables for Inspection by Attributes, should not be used for validation activities.
- Master game-changing shortcuts that will simplify your sample size calculation efforts and ultimately ensure better outcomes.
Regulatory authorities require risk-based sample sizes that have a sound statistical foundation. To ensure your organization can meet expectations — don’t miss this chance to gain key insights from a top expert in the field.
Meet Your Presenter
Steven Walfish, president of 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 has experience applying statistical methods to sample size determination, analytical method verification and validation and stability analysis.
Who Will Benefit
- Design engineers
- Process engineers
- Manufacturing engineers
- Quality assurance staff
- Regulatory staff
- Medical affairs/clinical affairs representatives
- Project/program managers
- Quality management system auditors
- Supply chain engineers
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Sept. 28, 2023