Handling of  Out of  Specifications

What will I learn from this course?

As a pharmacist or QA Professional working in the Pharmaceutical Industry, you will be responsible for overseeing any Out of Specifications (OOS’s) that may occur as part of the analytical testing of a pharmaceutical product. This training module will take you through the OOS process step by step, so that you will understand the science behind it. Once you understand the science of OOS, it will help you to make sound decisions. As the Marketing Authorisation Holder (MAH / Applicant), you ultimately have overall responsibility with regards to local release of product to market and hence you would need to be satisfied with the outcome of an OOS before you release the product to market.

Who would benefit from this course?

• Pharmacists and QA professionals who needs a better understanding of the management of analytical Out of Specifications or need a refresher