UE5FD008142

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 collecovelvly 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.

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Parenteral Drug Association

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

Center for Drug Evaluation and Research (CDER) [HHS - FDA]

Bethesda, Maryland 208144485 United States

Single Zip Code

Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed (RFA-FD-23-029)

Amendment Since initial award the total obligations have increased 157% from $1,750,000 to $4,500,000.