This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory (drug development) and clinical development (drug/device) procedures such as analytical methods in validation and acceptance criteria in calibration procedures, risk management and process monitoring as well as dealing with uncertainties and other relevant issues. It is not a course in statistics but introduces the participant to a hands on approach to the statistical techniques one uses, how they are applied and reasonably interpreted and understood.
Upon completing this course participants should be able to:
Evaluate linear and other quantitative measurement procedures.
Distinguish the difference between confidence and tolerance intervals.
Evaluate the sensitivity of the sample size in given procedures.
Evaluate laboratory/clinical data results based on risk management and design space issues.
Who will Benefit:
This course is designed for people responsible for developing, maintaining and/or improving clinical and laboratory monitoring programs and interpreting the results from such. This includes individuals that have data monitoring responsibilities. The following personnel will benefit from the course:
Assay Development Scientists
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