Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming ...
A major European contract manufacturing organization (CMO) producing diverse biologic drugs recognized the significant impact of the August 2023 EU GMP Annex 1 revision. This update, focused on ...
Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing ...
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure ...
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 ...
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 rapid evolution of telehealth is transforming how patients access — and physicians provide — care, a shift accelerated by policy changes adopted during the COVID-19 pandemic. The announcement in ...