martes, 22 de noviembre de 2016

Site Visit Training Program for Office of Pharmaceutical Quality Staff

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Site Visit Training Program for Office of Pharmaceutical Quality Staff
CDER has initiated various training and development programs, including the 2017 OPQ Staff 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 of the challenges that impact a drug’s development 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 is an integral part of the program.
In this site visit program, groups of OPQ staff—who have experience in a variety of backgrounds, including science, statistics, manufacturing, engineering and testing—will observe operations of commercial manufacturing, pilot plants, and testing 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 drug substances and drug products to respond.
DATES: Submit either an electronic or written proposal to participate in this program by January 17, 2017. Please refer to the Federal Register Notice for details.