2020 - Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies
Date2020-07-02
Deadline2020-06-21
VenueOnline event, USA - United States
KeywordsRification & Validation; Sample-Size Rationale; Sample Size
Topics/Call fo Papers
Introduction
Examples of regulatory requirements related to sample size rationale
Sample versus Population
Statistic versus Parameter
Rationales for sample size choices when using...
Confidence Intervals
** attribute data
** variables data
Statistical Process Control C harts (e.g., XbarR)
Process Capability Indices (e.g., Cpk )
Confidence/Reliability Calculations
** attribute data
** variables data (e.g., K-tables)
Significance Tests ( using t-Tests as an example )
** when the "significance" is the desired outcome
**when "non-significance" is the desired outcome (i.e., "Power" analysis)
AQL sampling plans
Examples of statistically valid "Sample-Size Rationale" statements
Examples of regulatory requirements related to sample size rationale
Sample versus Population
Statistic versus Parameter
Rationales for sample size choices when using...
Confidence Intervals
** attribute data
** variables data
Statistical Process Control C harts (e.g., XbarR)
Process Capability Indices (e.g., Cpk )
Confidence/Reliability Calculations
** attribute data
** variables data (e.g., K-tables)
Significance Tests ( using t-Tests as an example )
** when the "significance" is the desired outcome
**when "non-significance" is the desired outcome (i.e., "Power" analysis)
AQL sampling plans
Examples of statistically valid "Sample-Size Rationale" statements
Other CFPs
- Metrology - Statistical Analysis of Measurement Uncertainty
- Change Control for FDA Regulated Industries
- "Front-End, Middle, and Back-End" Approach to Credit Management
- Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
- Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Last modified: 2020-05-16 23:55:48