. ICH Q7 WEEK .
Speakers of the ICH Q7 Week 2017
Dr Andy Bailey
ViruSure GmbH, Austria
Dr Bailey has been actively involved in the pathogen safety of biopharmaceuticals for over 11 years. Originally a iochemist, 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 at expert workshops, including the UK MHRA, German PEI, French AFFSAPS, US FDA, EMEA and JMHLW (Japan).
Richard M. Bonner
Formerly Eli Lilly andCompany Limited, UK
Mr Bonner is currently located in the UK and works as a consultant to the Pharmaceutical Industry. Previous to his current role he was a Senior Quality Adviser for Eli Lilly and Company. He had 31 years experience within the pharmaceutical industry working in production, technical services and both Quality Control and Quality Assurance functions. He has been involved in multiple inspections from the MHRA, FDA and other authorities. He has also been instrumental in obtaining ISO9000-2000 accreditation for manufacturing sites. He has audited extensively throughout the EU and in countries as far a field as Canada, USA, China, Pakistan, Egypt, Syria, Oman and Russia. Mr Bonner is a Qualified Person in Europe. He is also Chairman of the European Compliance Academy.
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.
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.
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.
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.