FDA Accepts Submissions for Staff Learning Site Visit Program

CDER is inviting API and drug manufacturers to take part in the Office of Pharmaceutical Quality (OPQ)’s staff training site visit program for fiscal 2020.

OPQ encourages companies to apply for the program but says that participation won’t supplement or replace an agency inspection.

In the program, groups averaging 15 to 20 OPQ staff members will observe operations of commercial manufacturing, pilot plants and testing over one to two days. The facilities will be selected based on priorities identified for staff training, the facility’s compliance status, and on consultation with the FDA district office.