Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline
To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...
Read MoreBiotech’s Compliance Odyssey: Navigating the Revamped EU GMP Annex 1 in the Age of Innovation and Accountability
In the dynamic world of biotechnology, where innovation is moving at a rapid pace and patient safety is paramount, compliance with regulatory standards is non-negotiable....
Read MoreRevolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections
COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away,...
Read MoreMoving the Goalposts?
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management? (more…)
Read MoreAre You Ready? Major Changes Coming to Europe MDR and IVDR
Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the...
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