Education and Training Program for Outsourcing Facility Industry

PDA全球总部RFA-FD-23-029 贝塞斯达大厦， Suite 600 4350东西高速公路 Bethesda，MD 20814美国 电话：+1（301）656-5900 传真：+1（301）986-0296 该项目将支持以下任务：以医生为主导，现场和虚拟实验室为基础 在CGMP培训专门为外包设施行业或使用该公司的 现场微生物实验室和洁净室设施，专门为 外包设施行业，以及注册和后勤支持。 这三个部分将共同为建立一个可持续的培训计划奠定基础， FDA Compounding Quality Center of Excellence（食品药品监督管理局配料质量卓越中心） 讲师指导、现场面对面和虚拟培训：这部分资助机会包括 维护和提供由培训师主导的现场培训、面对面培训和虚拟培训， 规定用于无菌药物混合、环境监测、洁净室、研究和CAPA， 过程验证和质量管理体系，以及未来几年开发的任何课程。 自我指导在线培训：这部分资助机会包括开发至少一个 专门针对CGMP定制的CGMP主题（TBD）的自助式在线互动培训 要求的外包设施行业，但提供给任何人wanjiang采取的 课程这些培训旨在供外包机构、配制商、州监管机构使用， 和其他感兴趣的利益相关者，并且对开放获取的学员没有成本，与 TRAIN学习网老生常谈。 注册和登录支持：这部分资金机会包括监督和 与专业和高效地处理业务和后勤支持有关的管理，例如： 实施课程注册和后勤保障;进行和分析课程评估;收集 课程费用;收集和记录课程相关指标;以及监督和管理 所有课程的学分都是学分。 页1的1

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