Kite Pharma R&D Quality Internship: Poster Presented at PDA Week 2025.

Q3 Medicine

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-08-01 DOI:10.5731/pdajpst.2025.25404

Devon B Cooper, Caitlin Fisher, Marjorie Stevenson

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引用次数: 0

Abstract

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.

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风筝制药研发质量实习：2025年PDA周展示海报。

在Kite Pharma的研发质量（RDQ）实习为我提供了一个全面的介绍，以确保遵守卫生当局的法规，并在临床研发中培养质量驱动的文化。主要贡献包括通过协调临床试验时间表、进行差距分析和开发模拟检查文档，为监管检查做准备。我还支持标准操作规程（SOP）的更新，以提高一致性，并开发了引人入胜的培训材料，如质量GCP培训游戏，以加强员工跨部门和职能领域对良好临床操作规程（GCP）的理解。此外，我还进行了培训差距分析，以评估当前GCP审核报告的写作能力，并为未来团队培训材料的创建提供支持。总的来说，这次实习强化了质量在保护患者、确保产品可靠性和管理创新疗法开发风险中的重要性，并进一步激发了我对质量领域的兴趣。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

PDA Journal of Pharmaceutical Science and Technology Medicine-Medicine (all)

CiteScore

1.90

自引率

0.00%

发文量