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 Richard
Bonner
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
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.
 Dipl.-Ing.
Wolfgang Rudloff
Mechanical Engineer, legal expert in cleanroom technology and
GMP management, expert in Industrial Engineering, safety
engineer, worked in technical and process lead positions within
Warner Lambert-Gödecke in Freiburg. His qualification comprises
lead auditor, head of construction management,
process engineering, GMP consultancy. In 2001, after the
position as managing director of LSMW, Switzerland he became
managing director, senior consultant and senior auditor for PCS
(Pharmaceutical Consultancy
Services).
 Yves
Samson
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 Berthold Stemmle
From 1974 – 1989, Berthold Stemmle worked for Boehringer
Mannheim in the development of solid diagnostic and therapeutic
dosage forms combined with development of new pharmaceutical
technologies. After that he was employed by Solvay
Pharmaceuticals in Hannover for many years. His area of
responsibility embraced the whole range of pharmaceutical
development , i.e. drug product and process development from lab
scale to production scale, manufacturing and packaging of
investigational medicinal products as well as QC and QA in
development. He conducts GMP audits of API and Drug Product
Manufacturers worldwide.
 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.
TMark 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 Hans-Peter Volkland
For several years, Hans-Peter Volkland worked in R&D and in
various quality-relevant positions (QA, QC, validation and
qualification). In 2001, he became Senior Consultant and Senior
Auditor for PCS (Pharmaceutical Consultancy Services). Today, he
is a freelance consultant and specialises in GMP consulting,
auditing and training for the pharmaceutical and API industry.
 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.
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