Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
Instructor:
Elaine Eisenbeisz
Product ID: 706650
- Duration: 90 Min
Why Should You Attend:
Verification and validation studies of design-outputs and/or manufacturing processes are required in many manufacturing processes. However, it can be difficult to understand the rational for same sizes used in these contexts. This webinar will be useful to those interested in learning how to make and justify the reasoning behind sample size determination.
Learn the theory, terminology, regulatory requirements, best practices, and of course, the steps for calculating sample sizes for process verification and validation.
NOTE: This webinar does not address rationales for sample sizes used in clinical trials.
Learning Objectives:
- Understand statistical concepts and terminology related to sample size determination
- Use of open-source GPower software to perform sample size calculations
- How to write a justification statement for the rationale used to determine sample size.
Areas Covered in the Webinar:
- Regulatory Requirements for sample size in verification and validation
- Population vs. Sample, Statistical Theory and Terminology
- Confidence Intervals
- Statistical Process Control Charts
- Process Capability Indices
- Confidence/Reliability Calculations
- Tests of Significance
- Mean Time Between Failure (MTBF) studies
- Example of sample size determination
- Tips for writing “sample size rationale” statements that are statistically sound.
Who Will Benefit:
- QA/QC Supervisor
- Process Engineer
- Manufacturing Engineer
- QA/QC Technician
- Manufacturing Technician
- R&D Engineer
Elaine Eisenbeisz
Owner, Omega Statistics
Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California.
Elaine earned her B.S. in Statistics at UC Riverside and received her Master’s Certification in Applied Statistics from Texas A&M.
Elaine is a member in good standing with the American Statistical Association and a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.
Elaine has designed the methodology and analyzes data for numerous studies in the clinical, biotech, and health care fields. Elaine has also works as a contract statistician with private researchers and biotech start-ups as well as with larger companies such as Allergan, Nutrisystem and Rio Tinto Minerals. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
