. ICH Q7 WEEK .
Speakers of the ICH Q7 Week 2018
Mr Gengenbach is founder and managing director of gempex Co. Ltd., Germany. He is member of different organisations, among others DIN UA2 (Board for standards ‘biotechnology’), of DECHEMA and ISPE. He is approved Quality Auditor according to DIN ISO 9000ff.
Dr Holger Kavermann
Roche Diagnostics, Germany
Dr Kavermann studied microbiology at the University of Gottingen and obtained his PhD in medical microbiology at the University of Munich. In 2003 he joined Roche Diagnostics GmbH, as Manager QC. He is responsible for the microbiological and cell biological analytics of QC- and In-Process-Control-samples in the production of biotechnological derived active pharmaceutical ingredients.
Steris Corporation, USA
Paul Lopolito is a Technical Services Manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process research cleaners, stainless steel maintenance, and contamination control, which includes field support, site audits, training presentations and educational seminars. He has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. He is a frequent speaker at industry events including INTERPHEX, PDA, ISPE, ACHEMA, AALAS, and IVT. He has published several articles and book-chapters related to cleaning validation and contamination control. He earned a BA in Biological Sciences from Goucher College in Towson, MD.
Roche Diagnostics, Germany
Sabine was trained as medical-technical analyst and biotechnician, started at Roche Diagnostics GmbH in 2000 and throughout the last 14 years within the Roche Pharma QC she filled roles as specialist for cleaning validation as well as method validation for biochemical and microbiological laboratories. Currently Sabine is acting as expert for cell bank Releases.
Dr Rob Slobbe
Philips Image Guided Therapies The Netherlands
Dr Rob Slobbe is Head of Quality & Regulatory with Philips Image Guided Therapies – Business Incubation. He steers the Philips organization as responsible Q&R executive towards regulatory and quality compliance with medical device and pharmaceutical regulations, particularly through the design and implementation of quality management systems meeting appropriate cGMP standards. Moreover, Dr Slobbe is specifically responsible for supplier qualification and evaluation and redesigning Philips internal processes to foster innovation. Dr. Slobbe is an experienced cGMP auditor, covering good industry practices and compliance of systems, facilities and operations and since 2001 has carried out numerous audits as lead auditor on behalf of the independent third party auditing program of APIC.
Dr Paul Stockbridge,
Stockbridge Biopharm Consulting, UK
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.
Janssen Pharmaceutica, Belgium
Graduated in 1979 as Bachelor in Chemistry. He joined Janssen Pharmaceutica (part of Johnson & Johnson) in 1981 in chemical development. Until 1995 increasing responsibilities within the organisation mainly in the Quality Control Unit (Manager QC Lab 1994). Starting from 1995 he joined the QA department. Several Senior Manager responsibilities (sGMP Auditor – Release – Quality Systems). 2005 Sr Manager GMP Compliance Chemical Operations Belgium (sites Geel – Olen – Beerse). 2009 Director Global Compliance EMEA/AP for Johnson & Johnson.
Dr Jos van der Ven,
Aspen Oss B.V., The Netherlands
Jos van der Ven studied Chemistry at Utrecht University (the Netherlands) where he obtained his PhD in Bio-organic Chemistry in 1993. after a postdoc, he joined Quest International (currently Givaudan) as project manager R&D.. He then moved to Diosynth Oss and held different positions in API Manufacturing with increasing responsibilities for 8 years. After a period as plant manager, he joined the Quality department as a QA manager for (bio)chemical APIs for 8 years. During this period he contributed to the subsequent transitions as a result of the takeovers by Schering-Plough, MSD and latest Aspen Pharmacare. His activities in API manufacturing covered subjects such as cleaning in (bio)chemical production, deviation and change control, release, ‘QA-on-the-floor’, inspections by e.g. IGZ and
FDA, and a SAP implementation. Currently he is Business Process Manager Quality at Aspen Oss B.V..
Peter C. Zimmermann
Mr Zimmermann is supervisor BDP and specialised in work- and organisational psychology. His responsibility includes among other things training of communication and conversation skills, rhetoric and presentation techniques, argumentation and negotiation as well as leadership and motivation. During the last years he has trained more than 500 Auditors.