Education and Training Program for Outsourcing Facility Industry

Parenteral Drug Association, Inc., Bethesda MD

Investigators

Abstract

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