Pharma 4.0™ is an initiative by ISPE and its members to integrate "Industry 4.0" technologies and practices in pharmaceutical engineering. One of its goals is to establish a SMART Factory operational model. The success of this initiative depends on human factors, including professional and cultural aspects such as the Culture of Quality. According to the US FD&C Act, appropriate scientific training and experience are necessary to assess the effectiveness of these efforts fairly and responsibly. This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. It proposes a SMART framework to incorporate Human 4.0 into a corporate management system. The framework can ensure the integrity of not only the data but also the knowledge and wisdom needed to achieve the goals of Pharma 4.0™.
Dr. Ajaz Hussain is an independent advisor with extensive experience in academia, the US FDA, and the pharmaceutical, tobacco, and IT industries. He specializes in validating evidence of quality, safety, and effectiveness. He has held several key positions: President of the National Institute of Pharmaceutical Technology and Education (NIPTE), President of Biotechnology & CSO at Wockhardt Ltd, CSO and VP of Next Generation Product Assessment at Philip Morris International, Global Head of Biopharmaceutical Development at Sandoz, Deputy Director of the Office of Pharmaceutical Science at FDA, Associate Professor at the University of Cincinnati, and Assistant Professor at Ohio Northern University. Throughout his career, he has received numerous awards, and he is a Fellow of the American Association of Pharmaceutical Scientists and the Swiss Society of Pharmaceutical Sciences.
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