Daniel J. Roberts has over 19 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was a US FDA investigator for eight years, including two years as the primary point of contact for conducting pharmaceutical inspections at the FDA India Office, New Delhi. As an investigator, Daniel conducted preapproval and for-cause investigations and inspections of pharmaceutical manufacturers of human and veterinary sterile and nonsterile finished dosage forms and APIs worldwide. In his current position, he guides domestic and international clients in preparation for and management of FDA preapproval inspections and systems-based inspections and related activities. Daniel has a BS in molecular cellular and developmental biology from the University of California, Santa Cruz. He is a member of the ISPE Pharma 4.0™ SIG holistic control strategy working group.