Principal Consultant Statistical Outsourcing Services Rockville, Maryland
When validating a process or method, often the study design is flawed. Most guidance documents do not specify sample size nor do they give suggested approaches for how to design a good statistical study. This presentation will present the pitfalls of poorly designed validation studies, and some practical tips for mitigating the issues. Participants will understand the motivation for well-designed studies.
Learning Objectives:
Upon completion, participants will be able to understand how sample size impacts risk post validation,
Upon completion particpants will be able to design validation studies that will demonstrate the intended purpose.
Upon completion particpants will be able to analyze data to show equivalency between methods.
Upon completion particpants will be able to recognize poorly deisgned validation studies
Upon completion particpants will be able to interface with statisticians when dealing with complex problems..
