Education and Training Program for Outsourcing Facility Industry

PDA全球总部RFA-FD-23-029 贝塞斯达大厦， 600套房 4350号东西高速公路 美国马里兰州贝塞斯达，邮编20814 电话：+1(301)656-5900 传真：+1(301)986-0296 该项目将支持以下任务：讲师指导、现场直播和基于虚拟实验室 专门为ENƟRe外包设施行业量身定做的CGMP培训 现场微生物学实验室和洁净室设施，自助在线培训，专为 外包设施行业，以及RegistraƟon和LogisƟCall支持。 这三个部分将共同为建立可持续的培训计划而建立FoundaƟƟOn FDA配方质量卓越中心。 讲师指导、面对面现场培训和虚拟培训：此PorƟ提供的资助机会包括 维护和提供讲师指导、现场现场培训和虚拟培训的现有Ɵng门户 用于无菌药物配制、环境监测、洁净室、InvesƟgaƟon和CAPA， 过程验证Ɵon和质量管理系统，以及未来几年开发的任何课程。 自我指导的在线培训：此PorƟ提供的资助机会包括开发至少一个 针对专门为CGMP量身定做的CGMP主题(待定)的自导式在线互动ƟVE培训 EnƟre外包设施行业的要求，但任何想要Ɵng的人都可以使用 课程(S)。这些培训旨在供外包设施ƟES、复合商、州监管机构、 和其他感兴趣的利益相关者，而且对具有开放访问的学员来说是免费的，与Ɵ相比 培训学习网络平台。 注册和后勤支持：这份关于融资机会的PorƟ包括监督和 与专业、高效地处理OPERAƟ和LOGISƟ呼叫支持相关的管理，例如： ExecuƟng Course RegistraƟon和LogisƟcs；conducƟng并分析过程评估Ɵon；colcƟng 课程费用；CollecƟng和ReporƟng课程相关指标；以及监督和管理 ConƟNing Education aƟ为所有课程提供学分。 第1页，共1页

PDA Global Headquarters RFA-FD-23-029 Bethesda Towers, Suite 600 4350 East West Highway Bethesda, MD 20814 USA TEL: +1 (301) 656-5900 FAX: +1 (301) 986-0296 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