Regulatory Requirements training

Design & Analysis for AMDV
R101 - 1 day

The goal of this workshop is to help you to generate, analyse and interpret analytical data in support of method qualification, development, validation, technology transfer and routine use. It will help you to determine whether the methods and technologies you employ are fit for their intended use, and if not, to establish what appropriate actions need to be taken. The philosophy is to ensure that those closest to the instruments and methods are empowered with the necessary statistical tools to master their data.

You’ll get hands-on experience of applying the statistical techniques employed in Analytical Methods Development, and of managing and interpreting the associated scientific data. During the workshop, you will address the challenges raised through the successive phases of AMDV – and you will increase your understanding of what is involved; why it is important; when it should be done, and how it can be best and most economically achieved.

Topics covered

  • Qualification - basic statistics to evaluate ICH parameters (e.g., Accuracy, Linearity and Precision), as well as to determine the ideal replication scheme
  • Development - design of experiments to identify and optimise the key method control parameters to increase the likelihood of meeting requirements
  • Validation - in depth use of the statistical tools relevant to test the ICH parameters and establish whether a method is fit for its intended use
  • Technology Transfer - testing for difference or equivalence between methods, instruments, originating and receiving sites
  • Routine Use - data monitoring and trending to ensure the method maintains acceptable performance

Software Tools Used

We regularly run this course using the following software packages, but please just contact us if you'd like to discuss using your current in-house tool instead:

Attendees may also be interested in exploring Prism's free online Basic Statistics and Nested tools.

Who should attend?

  • All scientists involved in analytical method qualification, development, validation, technology transfer and routine use.

Recommended Preparation

No special preparation required

Please also see the following workshops:

There are no public workshops currently scheduled for this course - please contact us to learn when we'll next be running it.