FDA/CDER Site Visit Training Program for Office of Pharmaceutical Quality Staff

Site Visit Training Program for Office of Pharmaceutical Quality (OPQ) Staff

FDA's Center for Drug Evaluation and Research (CDER) has initiated various training and development programs, including the 2018 Experiential Learning Site Visit Program. This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience.

In this site visit program, groups on average of 15 to 20 OPQ staff will observe operations of commercial manufacturing, pilot plants, and testing operations over a 1- to 2-day period. To facilitate the learning process for OPQ staff, overview presentations by industry related to drug development and manufacturing may be provided, which may allow the participating sites to benefit by having an opportunity to showcase their technologies and manufacturing processes. OPQ encourages companies engaging in the development and manufacturing of both activepharmaceutical ingredients (small and large molecules) and drug products to respond.

This site visit program is not intended to supplement or replace a regulatory inspection. OPQ staff participating in this program will benefit by gaining a better understanding of current industry practices, processes, and procedures.

DATES: Submit either an electronic or written proposal to participate in this program within 60 days of the publication of the Federal Register Notice at Federal Register Notice.