凯特制药研发质量实习:海报在2025年PDA周发布
Devon B Cooper1, Caitlin Fisher2, Marjorie Stevenson2
1Keck Graduate Institute, Claremont, CA 91711, USA dcooper23.kgi@gmail.com.
PDA journal of pharmaceutical science and technology
|August 1, 2025
概括
这次实习的重点是通过改善监管合规性和员工良好临床实践 (GCP) 培训来提高临床研究和开发的质量保证. 主要活动包括准备检查和更新标准操作程序 (SOP).
科学领域:
- 药品质量保证 药品质量保证 药品质量保证
- 临床研究和开发 临床研究和开发
- 监管合规性 监管合规性
背景情况:
- 确保遵守卫生当局法规在制药研发中至关重要.
- 以质量为导向的文化对于可靠和安全的药物开发至关重要.
- 对所有工作人员来说,有效的良好临床实践 (GCP) 培训至关重要.
研究的目的:
- 在Kite Pharma获得研发质量的实践经验.
- 为加强监管合规和质量文化做出贡献.
- 开发和实施培训材料,以改善GCP的理解.
主要方法:
- 通过时间表协调和差距分析,为监管检查做好准备.
- 开发模拟检查文档和更新标准操作程序 (SOP).
- 创建了引人入胜的培训材料,包括GCP培训游戏,并进行了培训差距分析.
主要成果:
- 成功支持监管检查的准备工作.
- 通过SOP更新提高一致性,通过培训举措改善GCP理解.
- 确定了GCP审计报告撰写方面的培训缺口,以告知未来的发展.
结论:
- 实习加强了质量在患者安全,产品可靠性和风险管理方面的关键作用.
- 加强对强大的质量系统在创新疗法开发中的重要性的理解.
- 进一步巩固了对在制药质量保证领域的职业生涯的兴趣.
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