EANM guideline on quality risk management for radiopharmaceuticals
Sign Up to like & getrecommendations! Published in 2022 at "European Journal of Nuclear Medicine and Molecular Imaging"
DOI: 10.1007/s00259-022-05738-4
Abstract: This document is intended as a supplement to the EANM “Guidelines on current Good Radiopharmacy Practice (cGRPP)” issued by the Radiopharmacy Committee of the EANM (Gillings et al. in EJNMMI Radiopharm Chem. 6:8, 2021). The… read more here.
Keywords: risk management; medicine; eanm guideline; quality risk ... See more keywords
[Radiotherapy quality and risk manager role optimization in 2017].
Sign Up to like & getrecommendations! Published in 2017 at "Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique"
DOI: 10.1016/j.canrad.2017.07.025
Abstract: The quality and risk manager works in a regulated framework, which delimits its missions. Nevertheless, the variety among the centers generates heterogeneous situations regarding the positioning and the range of action. A well-defined framework is… read more here.
Keywords: radiotherapy quality; quality risk; risk manager;
Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
Sign Up to like & getrecommendations! Published in 2017 at "PDA Journal of Pharmaceutical Science and Technology"
DOI: 10.5731/pdajpst.2016.007096
Abstract: In this case study, the principles of quality risk management were applied to review sampling points and monitoring frequencies in the hormonal tableting unit of a formulation development pilot plant. In the cleanroom area, premises… read more here.
Keywords: risk; development pilot; environmental monitoring; monitoring ... See more keywords
Quality Risk Management - A Role-Based Competency Model.
Sign Up to like & getrecommendations! Published in 2019 at "PDA journal of pharmaceutical science and technology"
DOI: 10.5731/pdajpst.2019.010496
Abstract: In collaboration with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland, a research study exploring the need for developing QRM role-based competencies, as fundamental… read more here.
Keywords: methodology; research; risk management; competency model ... See more keywords