Daniel J. Roberts

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Hogan Lovells
Senior Specialist Pharmaceutical and Biotechnology Practice
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.

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Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™

The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the...