# Education and Training Program for Outsourcing Facility Industry

> **NIH FDA UE5** · PARENTERAL DRUG ASSOCIATION, INC. · 2024 · $1,250,000

## 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.
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## Key facts

- **NIH application ID:** 10920452
- **Project number:** 5UE5FD008142-02
- **Recipient organization:** PARENTERAL DRUG ASSOCIATION, INC.
- **Principal Investigator:** Mike Porter
- **Activity code:** UE5 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $1,250,000
- **Award type:** 5
- **Project period:** 2023-09-30 → 2027-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920452

## Citation

> US National Institutes of Health, RePORTER application 10920452, Education and Training Program for Outsourcing Facility Industry (5UE5FD008142-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10920452. Licensed CC0.

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