SNMMI Leadership Update: Quality Systems Personnel Training Program for Radiopharmaceutical Manufacturing.

نویسنده

Sally W Schwarz

چکیده

T he manufacture of radiopharmaceuticals is dependent on skilled personnel who are cross-trained in several disciplines, and currently too few people have the necessary training. To fill this educational gap, SNMMI is spearheading the development of a Quality Systems Personnel Training Program to cross-train chemists and pharmacists—providing the theoretical knowledge and practical experience needed to assume responsibility for the small-scale manufacture, quality control, and release of radiopharmaceuticals. Specific needs include cross-training in the principles and practice of radiopharmaceutical science; manufacturing and quality assurance of radiopharmaceuticals—both in the academic and commercial settings; synthesis and pharmaceutical formulation of radiopharmaceuticals, especially from cyclotron-produced radionuclides; application of radiopharmaceuticals in biomedical research and clinical nuclear medicine; and compliance, including all regulatory requirements associated with radiopharmaceutical manufacture and release. The target learners would have either a PharmD, BS, or MS in pharmacy or an MS or PhD in chemistry or radiochemistry. The goal is to prepare individuals to:

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