Frank Settineri, BS, MS, has over 30 years’ experience working with a range of entities from compounding pharmacies to pharmaceutical companies, focusing on investigations, root cause analysis, microbiological data deviations, particulate matter mitigation, and cGMP compliance. He is particularly adept in writing responses to 483s and warning letters that result in both interim controls and sustained cGMP compliance. Frank is president and founder of Veracorp LLC, a consulting firm with a client base including compounding pharmacies, sterile facilities, API manufacturers, oral dosage manufacturers, and microbiology laboratories.