Dick Bonner was Senior Quality Advisor for Eli Lilly and Company and worked there many years in responsible positions, among others in the fields of Regulatory Affairs, Quality Control and Quality Assurance. All in all, he can look back on 31 years of experience in the pharmaceutical industry, working in production, technical services, human resource management as well as in QC and QA. In addition, he was involved in a large number of inspections conducted by MHRA, FDA, EMEA and other authorities.
|Dr Christopher Burgess
Chris Burgess is a chemist with more than 30 years‘ experience in the pharmaceutical industry, the greatest part of which he gathered in quality assurance and analytical R&D at Glaxo. He is a Qualified Person and official assessor for ISO 17025 and has published more than 60 papers and books on topics concerning analytical quality assurance. He has wide-ranging experience in the application of statistical methods for data interpretation and analysis and is a member of the scientific advisory board of the US-American PDA Task Force on OOS results.
|Dr Marcel Goverde
Mr Goverde led the QC-Labs for non-sterile product testing, growth promotion, container closure testing, environmental monitoring and preservative effectiveness testing at F. Hoffmann-La Roche Ltd. and he worked as a QC expert for microbiology at the chemical department of Novartis Pharma. He owns a Green Belt in LEAN Six Sigma. Since 2003 he is the Swiss delegate in the EDQM group for modern microbiological methods.
|Dr Josef M. Hofer
From 1999 to 2002, Dr Hofer headed the department International Drug Regulatory Affairs of Klinge Pharma in Munich, Germany. Since 1999 he has also been a lecturer for the master's degree course on Regulatory Affairs of the University of Bonn. Dr Hofer is an expert on topics regarding the registration of medicinal products as well as the creation of DMFs/ASMFs and CEPs..
|Dr Afshin Hosseiny
Afshin Hosseiny is a former Director of Quality Assurance within Global Quality Assurance for GlaxoSmithKline (GSK). He worked over 20 years in the pharmaceutical industry in a wide variety of roles with increasing responsibilities; initially in Analytical Services, later in Quality Assurance on a Manufacturing Site and ultimately within the Corporate Quality Assurance function. He also has extensive experience in production monitoring, batch release, laboratory testing and validation for pharmaceutical active ingredients and finished products. Afshin Hosseiny is a Qualified Person via permanent provisions (CPD 2003).
|Dr Ursula Koller
Dr Ursula Koller has a sound professional experience as a GMP inspector at the Austrian AGES PharmMed, which is in charge of sovereign duties in the field of regulatory and inspection on behalf of the Austrian government. She has conducted numerous regulatory GMP inspections on national level, both API and FDF producers, wholesalers, supply chain and QC labs. Moreover she was responsible for API and FDF inspections abroad in many countries in Asia, The Americas and non-EU countries. Before joining the GMP Inspectorate she worked for GlaxoSmithKline and Sandoz.
|Dr Bob McDowall
Analytical chemist with over 30 years experience including 15 years working in the pharmaceutical industry. He has been a consultant for 18 years and trained auditor with 16 years experience. He has been involved with the validation of computerised systems for over 20 years and is the author of a book on the validation of chromatography data systems. Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several journals.
|Dr Jörg Neumann
Dr Neumann is a chemist and can look back on almost 20 years of experience in the pharmaceutical industry. He started his industrial career as a postdoc at F. Hoffmann-La Roche in Basle. Until 2002 he held different leading positions in the field of R&D at Abbott GmbH & Co KG in Ludwigshafen, Germany, most recently bearing international responsibility. For Novartis Vaccines & Diagnostics (formerly Chiron Vaccines) in Marburg, he headed the quality assurance department. In 2008, he was responsible for the quality assurance at international contract manufacturers for several Novartis Vaccines & Diagnostics sites.
|Dr Heinrich Prinz
Heinrich Prinz could look back on many years working for Boehringer Mannheim (Roche Diagnostics), when he joined Biotest AG in 1991. There, he headed the central department of quality assurance for the fields of pharmaceuticals, medicinal products and diagnostics until the end of 2002. During that time he built up the quality management systems for medicinal products and medical devices in compliance with GMP and FDA requirements. .
As automation engineer and computer scientist, Yves Samson worked during 11 years at Novartis in Basel, where he acted as application engineer for process control systems, project engineer, technical project manager, and site engineer (maintenance & projects). Since 1992, he takes care of validation and qualification of computerised systems and IT infrastructure. Yves edited the french version of GAMP® 4, GAMP® 5, and PIC/S PI 011. He is member of the GAMP Europe Steering Committee as well as co-founder and Chair of GAMP Francophone.
|Dr Wolfgang Schumacher
worked for ASTA Medica and F. Hoffmann-La Roche and has more than 30 years of experience in the Pharmaceutical Industry. After a successful career in Cancer Research he focused on the management of national and FDA inspections, auditing of contract manufacturers and the accountability as QP. At Roche he established the IT quality assurance department and was recently accountable in Technical Operations as Vice Director for the GMP/CSV compliance of all global computer systems and the setup of the Data Integrity program, for Genentech as well.
|Dr Thomas Trantow
Thomas Trantow worked in the pharmaceutical industry for 13 years, 11 of which he spent as Head Analytical Development/ Deputy Head of Quality Control. Before that, he headed the analytical laboratory of a contract manufacturer for 4 years. His focus topics are method development/validation, HPLC, stability testing, quality control, product development/quality dossiers, bioavailability studies, project management, and EDP in analytics.
|Mark Tucker, Ph.D.
Mark Tucker was Senior Director, GMP Compliance at Genentech Inc., South San Francisco, USA, where he had the full strategic responsibility for GMP Compliance. Before joining Genentech in 2002, Mark was Director, Investigations Branch at the U. S. Food and Drug Administration (FDA). He also served as an Investigator and Compliance Officer with the FDA. He started his career as Assistant Professor at the University of Southern California and Adjunct Assistant Professor at the Research and Education Institute, Harbor/UCLA Medical Center.
|Dr Ingrid Walther
With more than 25 years professional experience in the pharmaceutical industry and in GMP consulting, Ingrid Walther gathered comprehensive know-how in more than 100 projects all over the world. After university, Ingrid Walther joined Fresenius AG, worked in R&D and in Quality Control / Quality Assurance, the department she headed before she took over project management responsibilities. At Pharmaplan (now: NNE Pharmaplan), an engineering and consulting company for the GMP-related industry, she was responsible for the Validation and GMP-compliance team and later acted as COO. Working self-employed since 2009, Ingrid Walther is leading e.g. US-FDA-GMP compliance projects and continuously broadens her auditing, mock-inspection, and training experience.
|Dr Bernd Renger
Bernd started his career at Hoechst AG as a research and development chemist. Since then, he has held several positions at Mundipharma, Byk Gulden (now Takeda) and Baxter BioScience in Vienna. In his last position he was VP of Quality Control at Vetter Pharma. Bernd is a Qualified Person and has been the Chairman of the European QP Association for many years.
|Dr Paul Stockbridge
Dr Stockbridge spent 23 years with Eli Lilly, initially in fermentation development and then in quality assurance where he became a Q.P. and Q.A. Advisor for biotechnology projects for which he travelled globally. He then moved to a Head of Quality Operations role with Aventis Pharma before being appointed to the role of Corporate Quality Director for Cobra Biomanufacturing Plc. After over 7 years with Cobra he is now providing independent consulting and training services for the steriles, aseptic and biotechnology industries. Paul has a degree in biology, a PhD in fermentation, is an EU Qualified Person and is a Fellow of the U.K. Society of Biology.