Douglas C Kovacs adopts a methodical and meticulous approach, focusing on the verification of sterility and potency claims in sterile preparations, the adequacy of sample testing controls, and the effectiveness of contamination control methods. He places significant importance on validation and demonstrable evidence of process effectiveness.

Douglas C Kovacs is a detail-oriented FDA auditor who places significant emphasis on the validation and assurance of sterility and potency in sterile preparations. He also focuses on the adequacy of controls in sample testing and the monitoring of non-viable particulates in aseptic fill processes. Additionally, he scrutinizes the validation process for sterilization, particularly in relation to media fill simulations, and the effectiveness of methods used for contamination control.