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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 Klaus Haberer
Klaus Haberer was awarded a PhD from University of Cologne in
1973. Associate professor (Privatdozent) at University of Ulm in
1983. Industrial positions 1983 to 1999 as head of
microbiological QC/QA departments at Hoffmann-La Roche AG,
Grenzach, and at Hoechst AG, Frankfurt, Global Director of
Microbiological QA/QC at Hoechst Marion Roussel AG in Frankfurt,
Germany, responsible for setting and supervising (auditing)
global microbiological quality guidelines within the
multinational company. Involved in numerous inspections and
negotiations with Authorities (incl. EMEA, FDA, Japan).
Delegated as a German Expert to European Pharmacopoeia. Convenor
of ISO Expert group Aseptic Processing of Medicinal Products
(ISO Standard 13408). Member of several PDA working groups and
member of PDA Scientific Advisory Board. In 1999 Dr Haberer
founded his own independent consultant firm, supporting the
pharmaceutical and other related industries in all
microbiological questions concerning manufacture of sterile
products under GMP, ISO and other international regulations.
 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. Studying
Pharmacy she graduated as a PhD at the University of Vienna,
Austria followed by a career in the pharmaceutical industry,
where she worked for GlaxoSmithKline and Sandoz. She is a
certified EOQ Quality Auditor and Quality Systems Manager.
 Dr
Bob McDowall
Analytical chemist with over 30 years experience including 15
years working in the pharmaceutical industry with 2
multinational companies. He has been a consultant for 18 years (general
management consultancy, business process optimisation and
electronic working practices) 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. |
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 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 (formerly Knoll AG) in
Ludwigshafen, Germany, most recently bearing
international responsibility. For Novartis
Vaccines & Diagnostics (formerly Chiron
Vaccines) in Marburg, he first headed quality
assurance/validation, later on, from November
2005, the entire quality assurance. In 2008, he
was responsible for the quality assurance at
international contract manufacturers for several
Novartis Vaccines & Diagnostics sites. Since the
beginning of 2009, Dr Neumann has been working
as a consultant for the pharmaceutical industry.
 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.
Later on, he combined the different systems to form an integrated
system. The focus of his activities is on building up and
implementing quality management systems in accordance with GMP
Parts I and II as well as integrated management systems, and
performing audits and training courses.
 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 Lamber - Gödecke in Freiburg. His qualification comprises
lead auditor, head of construction management, process
engineering, GMP - consultancy. After the position as managing
director of LSMW / Switzerland he became in 2001 managing
director, senior consultant and senior auditor for PCS
(Pharmaceutical Consultancy Services). Today, he is a freelance
consultant and specialises in technical
GMP-management, GMP consulting, auditing and training for the
pharmaceutical and API industry.
 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 worldwide GMP audits and gives advice/training to Suppliers of the Regulated Industries, API and Drug Product Manufacturers in all areas of GMP and QA (i.e. validation, qualification, establishing QA units).
Berthold Stemmle also has special know-how in optimisation of production processes.
 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.
 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.
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