This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques cover both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management.
It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. Data examples are abundant throughout the seminar. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations.
In this two-day seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are utilized, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how these guidelines are applied in practice.
Upon completing this course, participants should be able to:
- Evaluate linear quantitative measurement procedures and sources of error
- Distinguish the difference between confidence and tolerance intervals
- Evaluate the appropriateness of the effect of sample size in given procedures
- Evaluate laboratory/clinical quality control based on risk management
- Interpret statistical process control
- Distinguish between FDA requirements and ICH guidelines