Lothar Hartmann, PhD, obtained his diploma and PhD in technical chemistry from the Technical University of Berlin. He joined Hoffmann-La Roche in 1988 and served in numerous functions in the global Quality Department. Lothar acted as Head of Pharmaceutical Quality Systems and External Relations and Knowledge Management. In 2011, he became Head of Quality at a large Johnson & Johnson site before he became an independent consultant with PhACT. Lothar has served in numerous organizations such as APIC/CEFIC (Vice-Chair), European Biopharmaceutical Enterprises BioManufacturing Working Group (Chair), and PDA (Board of Directors, Quality Systems Interest Group Chair). Currently, he heads PDA’s Global Interest Group on Quality Systems and is actively involved in ISPE’s Pharma 4.0TM SIG. Lothar was part of the Expert Working Group of ICH Q7a. He has been an ISPE member since 2002.