Slip-ups resulting from a lack of knowledge, experience, or training can lead to delays or even regulator intervention, depending on the severity of the issue. Process development & optimization, raw material sourcing and qualification, quality control & testing, and documentation & batch record-keeping all must be aligned to ensure the GMP batch and, by extension, FIH batch production, is carried out successfully. Moreover, specialized individual and team training, as well as a concerted communication & collaboration campaign, are necessary to create an environment conducive to that success.