. ICH Q7 WEEK .
Speakers of the ICH Q7 Week 2019
Dr Andy Bailey
ViruSure GmbH, Vienna, Austria
Dr Bailey has been actively involved in the pathogen safety of biopharmaceuticals for over 11 years. Originally a Biochemist, Dr Bailey served for nine years at the MRC Virology Unit in Glasgow, Scotland. In 1995, he moved as Director of Virus Validation services to Q-One Biotech Ltd, and in 2001 to the Pathogen Safety group of Baxter Healthcare in Vienna, Austria. He was the main founder of ViruSure GmbH, a specialist virus safety testing company in Vienna, Austria, in 2005. Over the last 10 years, Dr Bailey has presented at numerous regulatory agencies on virus and prion safety, either in support of products or as an invited speaker in expert workshops. Ralf Gengenbach gempex, Germany 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 Göttingen 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.
Merck KGaA, Germany
Mr Mungenast studied Biology and Chemistry at the University in Karlsruhe. Then he worked in different functions for Merck KGaA. Since 1996 he is responsible for cleaning validation, training and different projects in the Quality Assurance department.
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.
VDWcGMP Consultancy, Belgium
Francois Vandeweyer 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. Starting from 1995 he joined the QA department. Several Senior Manager responsibilities. 2005 Sr Manager GMP Compliance Chemical Operations Belgium (sites Geel – Olen – Beerse). 2009 Director Global Compliance EMEA/AP for Johnson & Johnson. Since May 2019 he is a freelance consultant.
Dr Jos van der Ven
Aspen Oss B.V., The Netherlands
Dr Jos van der Ven 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.