Timothy Hawryluk adopts a comprehensive approach, with specific emphasis on validation of processes, skill level of personnel, and the adequacy of the control measures in place. He prioritizes aspects such as SOP, equipment maintenance, and design and pays deep attention to every detail, aiming for zero incidents of regulatory non-compliance.

FDA Investigator Timothy Hawryluk is extensively focused on the robustness of Standard Operating Procedures, equipment design, and maintenance, as well as the adequacy of investigations into batch failures. A distinctive highlight of his inspections is the rigorous examination of the validation of different processes like filling and decontamination. He also allocates detailed attention to personnel training and qualification, and aseptic controls.