Handle Out of Specification (OOS)


What will you learn?

Pharmacists and QA professionals in the pharmaceutical industry must oversee any Out of Specifications (OOS) that occur during the analytical testing of pharmaceutical products.
This module explains the science behind the OOS process step by step. When you understand the science of OOS, you can make sound decisions. As the Marketing Authorisation Holder (MAH / Applicant), you are ultimately responsibility for local release of products to market. You must be satisfied with the outcome of an OOS before you release product to market.

Who will benefit from this course?

Pharmacists and QA professionals who need to understand the management of analytical Out of Specifications better, or need a refresher.