Author: MTS

2022 Course Calendar

Our schedule of courses for 2022 is now available for you to download as a pdf, just click on the image in this post. The document is interactive and you can click on the course titles to access course information, and on the ‘Book Now’ buttons if you’re ready to make a booking. Contact us […]

Where do the Acceptance Criteria in Method Validation Come From?

Webinar Recording One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R1), don’t mention any numbers. In this […]

5 Golden Rules for Effective (and Inspection Ready) OOS Investigations

The investigation of out of specification (OOS) results is a regulatory requirement in a GMP laboratory and these investigations are intensively scrutinised by health authority inspectors. The purpose of this article is to provide 5 ‘Golden Rules’ which will make sure that investigations are both effective and inspection ready. Rather than use the term OOS […]