Devon B Cooper, Caitlin Fisher, Marjorie Stevenson
{"title":"风筝制药研发质量实习:2025年PDA周展示海报。","authors":"Devon B Cooper, Caitlin Fisher, Marjorie Stevenson","doi":"10.5731/pdajpst.2025.25404","DOIUrl":null,"url":null,"abstract":"<p><p>The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"430-431"},"PeriodicalIF":0.0000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Kite Pharma R&D Quality Internship: Poster Presented at PDA Week 2025.\",\"authors\":\"Devon B Cooper, Caitlin Fisher, Marjorie Stevenson\",\"doi\":\"10.5731/pdajpst.2025.25404\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.</p>\",\"PeriodicalId\":19986,\"journal\":{\"name\":\"PDA Journal of Pharmaceutical Science and Technology\",\"volume\":\"79 4\",\"pages\":\"430-431\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"PDA Journal of Pharmaceutical Science and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5731/pdajpst.2025.25404\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"PDA Journal of Pharmaceutical Science and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5731/pdajpst.2025.25404","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.