The course will provide the participants with recommendations, tools and examples to apply scientifically and pragmatically sound statistical principles to their day-to-day business as well as to meet future challenges described above.
The relevance of such statistical tools is also increasingly recognised by the Compendia, as reflected, for example, in the USP General Information Chapter <1010> “Interpretation and treatment of analytical data” and the recently introduced <1033> “Biological assay validation” together with USP Medicines Compendium, <10> “Assessing Validation Parameters for Reference and Acceptable Procedures”.
Statistical tools are needed, for example, to evaluate:
Distribution of data and its parameters
How to detect outliers and trends?
How to establish the total variability of the method?
How to identify method parameters that must be controlled?
Method performance and specification limits
Which accuracy and precision is needed to achieve
an acceptable risk of OOS results?
Scientifically based justification and optimisation of the reportable result (single or average?)
What are the requirements for impurity methods?
Comparison of methods and data
What are the requirements for calibration models?
How to optimise the number of calibration replicates on a scientific basis?
A brief discussion of supporting software tools (e.g.
Excel, Minitab, JMP) to facilitate the generation of statistical information in a consistent manner will be undertaken.
One of the main features of this new course is the
balance of presentations and more than five hours of practical exercise workshops which will allow participants to gain ‘hands on’ practical experience in applying the statistical methods described. By means of statistical simulation tools, the participants will gain intuitive understanding of the consequences of appropriate and
inappropriate performance parameters, for example the relationship between precision and OOS results.
For this reason, the course is limited to 30 participants
so that individual attention and support can be given. In order to fully benefit from the workshops, attendees should preferably bring a notebook with Excel® 2007 or later.