A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming ...

It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and ...

Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure ...

Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, aiming to ...

In the medical device industry, the stakes of an FDA inspection are high. Non-compliance can lead to delayed market access, product recalls, or regulatory actions that can jeopardize a company’s ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

Pharmaceutical drug complexity and regulatory demands are escalating, posing significant challenges for packaging integrity. To safeguard each precious dose, packaging must be held to the same ...