November 21, 2023 || LeAnna Pearson
Introduction PIC/S was founded in 1995 as an extension of PIC (Pharmaceutical Inspection Convention). They are a non-binding cooperative arrangement between 56 different Regulatory Authorities. Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S. Their…
November 20, 2023 || Rosario Hughes-Kielty
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 Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…
November 10, 2023 || Connie Leech
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. The newest regulation that biotech companies, operating in the European Union (EU) must now contend with is Annex 1 of the EU Good Manufacturing Practice…
November 10, 2023 || Connie Leech and Geraldine Carr-Mulry
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, drug shortages have persisted on a global scale. The demand for flexibility in the supply chain remains imperative, However, many drug manufacturers are still reluctant…
April 5, 2018 ||
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?
September 28, 2017 ||
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 In Vitro Device Regulations.
