Preparing SMEs for the Inspection


How to Select Your Subject Matter Experts (SMEs)

Although it can be an extremely effective way to handle a crucial aspect of the FDA inspection, designating SMEs can also backfire if the SME does a poor job during the interview. Read More

How to Train Your Subject Matter Experts (SMEs)

Section 704(a) of the Food, Drugs & Cosmetics Act (FDC Act) [21 U.S.C. 374 (a)] authorizes the FDA to enter drug and device factories, warehouses and other establishments to perform inspections. Read More