Dr. rer. nat. Lothar Hartmann
Throughout his 30-year long career he has gained outstanding experience in many aspects of quality, which enable him to provide top quality solutions to customers.
Knowing the characteristics of local as well as global business allows him to understand well the different views and needs. During his local engagement he managed successfully FDA inspections, improved Key Performance Indicators (KPIs) significantly, and created pragmatic and compliant solutions for the daily business. Globally he was able to influence a number of quality relevant documents and interact intensively with regulators.
During his participation in associations he contributed to numerous path-breaking documents, which sustainably influenced the development of GMP, especially in the areas of API and Biotechnology.
His broad knowledge in Quality Management and GMP enables him to analyse even the most complex situations and provide tailor-made solutions by taking a holistic view on the customer’s situation.
Managing Director Phact GmbH.
Managing Director IPQ Consulting.
Site Head of Quality of Crucell / Johnson & Johnson Group of Companies.
Global Head of Knowledge Management of F. Hoffmann-La Roche, Ltd., Pharmaceutical Division.
Global Head of External Relations & Pharmaceutical Quality Systems of F. Hoffmann-La Roche, Ltd., Pharmaceutical Division.
Global Head of GMP Compliance and Auditing of F. Hoffmann-La Roche, Ltd., Vitamin Division, Basel.
Plant Manager at F. Hoffmann – La Roche in Grenzach, Germany.
Lecturer at the Bern University of Applied Sciences, Bern / Switzerland.
Former member of the ICH Q7 Expert Working Group.
FDA Award (“Commissioner’s Special Citation”) as member of the ICH Q7 Expert Working Group.
PDA Distinguished Award in 2012 and 2014.
- Chair of Interest Group Quality Systems of ‘Parenteral Drug Association’ (PDA).
- Member of ISPEs ‘Special Interest Group’ (SIG) “Pharma 4.0”.
- Chair of the Advisory Board of the GMP Manual.
- Member of the PDA Board of Directors.
- Chair of BioManufacturing Working Group of the ‘European Biopharmaceutical Enterprises’ (EBE).
- Member of ‘European Ferderation of Pharmceutical Industries and Associations’ (EFPIA) Working Group Quality/MGMP.
- Member of PDAs Scientific Advisory Board.
- Member of the ‘Verband Forschender Arzneimittelhersteller’ (VFA) API Committee.
- Vice-Chairman of CEFIC/APIC (Active Pharmaceutical Ingredients Committee).
- Chair of CEFIC/APICs GMP Working Group.
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