1 Day Course
This one day course covers everything required to design the practical tests required to produce a basic analytical validation protocol, implement validation studies and report to regulatory guidelines. The material focusses on the practicalities of designing and performing a validation study and the reporting / review of the associated data.
You will gain a clear understanding of the main ICH validation paramenters and how we apply these in working practice to produce test solutions that meaningfully assess method quality. Each section is supported by workshops which build experience in reviewing validation data and using this to troubleshoot validation failures. This builds valuable practical skills that can be applied to the type of data and problems commonly encountered during typical validation work.
- We limit numbers to 10 per course so that each delegate gets the opportunity to ask questions and fully participate in tutorial exercises
- When delivered on-site we can design the course material to suit your specific training needs
- Customisable written assessments are available if required
Course Overview | Download course details »
“Method validation is the process of defining the performance required from an analytical method, and confirming that the method under consideration has performance capabilities consistent with what the application requires. Implicit in this is that it will be necessary to evaluate the method’s performance capabilities.”
This course introduces all the critical analytical parameters covered during a typical method validation study, highlighting ICH regulatory guidance and detailing how the protocol should be carried out and reported.
Who is this course for
This course is for LC or GC method developers who need to provide evidence of the reliability of analytical methods or to ensure that “off-the-shelf” validated methods are being used correctly.
It is also of benefit to those in a quality assurance or project management role who have to review validation protocols and reports.
Good knowledge of chromatography and associated data.
What you will learn
- What is analytical best practice
- What is method validation
- Who defines method validation requirements
- The relation between method development and validation
- Where validation fits in the QBD process in method development
- Troubleshooting validation failures
Defining extent and scope of Method Validation
- Overview of Equipment Validation
Why we perform method validation
Overview of ICH Guidelines
Experimental design for Analytical Method Validation
Validation Parameters and associated data troubleshooting workshos for:
- Linearity and Range