Education and Training Program for Outsourcing Facility Industry

外包设施行业教育培训计划

• 批准号: 10879992
• 负责人: David Talmage
• 金额: $ 175万
• 依托单位: PARENTERAL DRUG ASSOCIATION, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2027-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10879992
• 关键词: Education; Training; Program; Outsourcing; Facility

PDA Global Headquarters RFA-FD-23-029 Bethesda Towers, Suite 600 4350 East West Highway Bethesda, MD 20814 USA TEL: [phone] FAX: [phone] This project will support the following tasks: instructor-led, live in-person and virtual laboratory-based training in CGMP specifically tailored for the enƟre outsourcing facility industry at or using the firm’s onsite microbiology laboratory and cleanroom facility, self-guided online training tailored specifically for the outsourcing facility industry, and registraƟon and logisƟcal support. All three parts will collecƟvely establish the foundaƟon for building a sustainable training program for the FDA Compounding Quality Center of Excellence. Instructor Led, Live In-Person and Virtual Training: This porƟon of the funding opportunity includes maintaining and delivering the exisƟng portiolio of instructor-led, live, in person and virtual trainings as specified for Sterile Drug Compounding, Environmental Monitoring, Cleanroom, InvesƟgaƟons and CAPA, Process ValidaƟon and Quality Management Systems, and any courses developed in future years. Self-Guided Online Training: This porƟon of the funding opportunity includes developing at least one self-guided online interacƟve training on a CGMP topic (TBD) tailored specifically to the CGMP requirements for the enƟre outsourcing facility industry but available to anyone wanƟng to take the course(s). The trainings are intended for use by outsourcing faciliƟes, compounders, state regulators, and other interested stakeholders and are no cost to trainees with open access, compaƟble with the TRAIN learning network platiorm. Registration and Logistical Support: This porƟon of the funding opportunity includes oversight and management related to expertly and efficiently handling operaƟonal and logisƟcal support such as: execuƟng course registraƟon and logisƟcs; conducƟng and analyzing course evaluaƟons; collecƟng course fees; collecƟng and reporƟng course-related metrics; and overseeing and managing provision of conƟnuing educaƟon credit for all courses. Page 1 of 1

PDA 全球总部 RFA-FD-23-029 贝塞斯达塔， 600号套房 东西公路4350号 美国马里兰州贝塞斯达 20814 电话：[phone] 传真：[phone] 该项目将支持以下任务：讲师指导、现场和基于虚拟实验室的任务 专门为整个外包设施行业量身定制的 CGMP 培训，在公司的或使用公司的 现场微生物实验室和洁净室设施，专为客户量身定制的自助在线培训 外包设施行业以及注册和后勤支持。 所有三个部分将共同为建立可持续培训计划奠定基础 FDA 复合质量卓越中心。 讲师指导、面对面和虚拟培训：这部分资助机会包括 维护和提供现有的由讲师指导、现场、面对面和虚拟培训的部分 指定用于无菌药物配制、环境监测、洁净室、研究和 CAPA， 流程验证和质量管理系统，以及未来几年开发的任何课程。 自助在线培训：这部分资助机会包括开发至少一个 针对 CGMP 主题 (TBD) 的自导式在线互动培训，专为 CGMP 量身定制 整个外包设施行业的要求，但任何想要接受外包服务的人都可以使用 课程。这些培训旨在供外包工厂、复合商、国家监管机构、 和其他感兴趣的利益相关者，并且对于开放访问的学员来说是免费的，与 TRAIN学习网络平台。 注册和后勤支持：这部分资助机会包括监督和 与专业、高效地处理运营和后勤支持相关的管理，例如： 执行课程注册和后勤；进行和分析课程评估；收集 课程费用；收集和报告与课程相关的指标；并监督和管理提供 所有课程的继续教育学分。 第 1 页，共 1 页