Gathering Knowledge on the Validated or Compendial LC Method
Key learnings
- Method transfer challenges to fulfill System Suitability Test (SST) requirements and related regulations
- LC method risk assessment using fishbone diagrams and heat map tables
- Applying a retrospective Analytical Quality by Design (AQbD) approach to existing methods
- Determining the Method Operable Design Region (MODR) for compendial methods to enhance knowledge
Overview
Out-of-Specification (OOS) results in the regulated QC laboratory represent a major source of wasted resources in terms of investigation time, costs, and increased time to market.
The occurrence of OOS results originating in the lab can be significantly reduced by focusing on commonly neglected areas:
- Is the instrumentation being used fit for its intended purpose?
- Is the analytical procedure well understood?
- Are the users appropriately trained?
Presenter: Alec Kettle (Pharmaceutical Specialist, Northern Europe, Waters)
Alec started his career at Waters in 2014 as a Chemistry Specialist before quickly moving into a System Sales Account Manager role in 2016 where he gained extensive knowledge and experience of the Pharmaceutical industry through account management of large Pharma and Contract Organisations. In his current role he is responsible for developing the Core Pharma, small molecule business in drug discovery, development and manufacturing/QA/QC across Northern Europe.
