The MTS consultant, Oona McPolin, will be presenting at the upcoming JPAG symposium at the RSC in London on the topic of analytical method transfer.
Tag: Lifecycle
New dates in 2026 for the course, ‘What’s New in ICH Q2(R2) and Q14?’
We have added two new dates in 2026 for our course, ‘What’s New in ICH Q2(R2) and Q14?’ in September and November. On this course you will learn about the recent changes to the ICH guidance, Q2(R2), ‘Validation of Analytical Procedures’, and about the new guidance Q14, ‘Analytical Procedure Development’.
When do I Need to Follow ICH Q2(R2) & Q14?
MTS HELPDESK:
When do I have to start following the updated ICH guideline, Q2(R2) and the new guideline, Q14?
Why Perform a Validation Gap Assessment?
MTS HELPDESK:
Why would it be necessary to perform a gap assessment of validation data that has been generated following ICH guideline, Q2(R1) against the updated version, Q2(R2)?
ICH Q2(R2) Validation Gap Assessment
MTS HELPDESK:
What are the differences between the ICH guideline, Q2(R1) and the updated version, Q2(R2), that would be identified in a gap assessment of an analytical procedure validation study which was originally performed following version Q2(R1)?
ICH Q2(R2)/Q14 IWG Training Materials
Training materials created by the Q2(R2)/Q14 ICH Working Group, relating to ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development”, are now available on the ICH Website. There are 7 training modules provided as pdf documents which aim to facilititate interpretation and implementation of the guidelines. The training materials are available for […]