This course is designed to offer a lifecycle approach to assuring analytical methods are suitable for their intended use. After an introduction to the stages of an analytical method, we will discuss each in more detail including concepts and practical suggestions. We will use concepts from ICH and USP documents as well as some additional concepts from a recent paper on a QbD approach to method lifecycle.
Upon completion of the course the learner should be able to:
- Identify the various stages in the lifecycle of an analytical method and the expectations at each of those stages.
- Apply the concept of the Analytical Target Profile for improving the design and evaluation of analytical methods.
- Discuss the appropriate guidance documents related to method validation, verification and transfer.
- Identify the required elements for method validation, verification or transfer experiments.
- Troubleshoot methods which are not performing well.
Who Will Benefit:
Chemists or managers responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.
- QC personnel
- QC Supervisors and Management
- QA personnel
- QA Management
- Regulatory affairs personnel
- R&D Lab personnel
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