Cooperative Agreement UE5FD008142

Award Date 9/30/23
Completion Date 9/30/27
Dollars Obligated $4.3M
Federal Grant Program
93.103
Assistance Type
Cooperative Agreement
Place of Performance
Bethesda, MD 20814, USA
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EDUCATION AND TRAINING PROGRAM FOR OUTSOURCING FACILITY INDUSTRY - 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 ENORE 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 REGISTRAOON AND LOGISOCAL SUPPORT. ALL THREE PARTS WILL COLLECOVELY ESTABLISH THE FOUNDAOON FOR BUILDING A SUSTAINABLE TRAINING PROGRAM FOR THE FDA COMPOUNDING QUALITY CENTER OF EXCELLENCE. INSTRUCTOR LED, LIVE IN-PERSON AND VIRTUAL TRAINING: THIS POROON OF THE FUNDING OPPORTUNITY INCLUDES MAINTAINING AND DELIVERING THE EXISONG PORTIOLIO OF INSTRUCTOR-LED, LIVE, IN PERSON AND VIRTUAL TRAININGS AS SPECIFIED FOR STERILE DRUG COMPOUNDING, ENVIRONMENTAL MONITORING, CLEANROOM, INVESOGAOONS AND CAPA, PROCESS VALIDAOON AND QUALITY MANAGEMENT SYSTEMS, AND ANY COURSES DEVELOPED IN FUTURE YEARS. SELF-GUIDED ONLINE TRAINING: THIS POROON OF THE FUNDING OPPORTUNITY INCLUDES DEVELOPING AT LEAST ONE SELF-GUIDED ONLINE INTERACOVE TRAINING ON A CGMP TOPIC (TBD) TAILORED SPECIFICALLY TO THE CGMP REQUIREMENTS FOR THE ENORE OUTSOURCING FACILITY INDUSTRY BUT AVAILABLE TO ANYONE WANONG TO TAKE THE COURSE(S). THE TRAININGS ARE INTENDED FOR USE BY OUTSOURCING FACILIOES, COMPOUNDERS, STATE REGULATORS, AND OTHER INTERESTED STAKEHOLDERS AND ARE NO COST TO TRAINEES WITH OPEN ACCESS, COMPAOBLE WITH THE TRAIN LEARNING NETWORK PLATIORM. REGISTRATION AND LOGISTICAL SUPPORT: THIS POROON OF THE FUNDING OPPORTUNITY INCLUDES OVERSIGHT AND MANAGEMENT RELATED TO EXPERTLY AND EFFICIENTLY HANDLING OPERAOONAL AND LOGISOCAL SUPPORT SUCH AS: EXECUONG COURSE REGISTRAOON AND LOGISOCS; CONDUCONG AND ANALYZING COURSE EVALUAOONS; COLLECONG COURSE FEES; COLLECONG AND REPORONG COURSE-RELATED METRICS; AND OVERSEEING AND MANAGING PROVISION OF CONONUING EDUCAOON CREDIT FOR ALL COURSES. PAGE 1 OF 1

Posted 9/5/23, 12:00 AM