Course offering number:0811-102
Course ID:
2047
Laboratory Control System
3-5 November 2008
Amsterdam, The Netherlands
Dr. John G. (Jerry) Lanese; President, The Lanese Group, Inc.
Dr. John G. (Jerry) Lanese, an independent consultant to the
pharmaceutical industry, received a Ph.D. in Analytical Chemistry
from the University of Michigan and began his career teaching
Analytical Chemistry in a small liberal arts college. He moved from
the academic environment to the pharmaceutical industry where
he has managed Analytical Research, Quality Control and Quality
Assurance functions.
Since 1994 Dr. Lanese has been a consultant in the area of cGMP
compliance and has consulted with small and large medical device
and pharmaceutical companies, including companies under FDA
Consent Decree, API and excipient manufacturers, electronic firms
and other manufacturing organizations.
Dr. Lanese lectures throughout the world on a variety of topics
related to Quality Systems, GMPs, APIs, laboratory operations,
calibration, computer system validation and electronic
documentation, change control, deviations and product reviews. In
2005, his article “Training and the Laboratories” was selected as
best article of year by the Journal of GXP Compliance. In 2007 he
received the Kenneth G. Chapman Industry Recognition Award for
his contributions to the Pharmaceutical Industry.
A member of the Editorial Board of the Journal of Validation
Technology, Dr. Lanese has been active in the Kansas Award for
Excellence program and has served as Examiner, Lead Examiner
and Judge. Dr. Lanese is also a member of American Society for
Quality, AOAC and the Institute for Management Consultants. He
is a Certified Management Consultant.
Dr. Alan J. Smith; Pharmaceutical and Technology Consultant
Dr. Alan J. Smith is a consultant specializing in pharmaceutical
quality and technology. He was formerly the Corporate Director of
Quality Affairs for the Whitehall Laboratories Division of American
Home Products Corporation (now Wyeth) following a career with
the Ayerst Division. He received his B.Sc. and Ph.D degrees from
the University of London in the UK and also studied Business
Administration at the Wharton School of the University of
Pennsylvania. He has been President of the Montreal
Pharmaceutical Discussion Group and Chairman of numerous
pharmaceutical conferences. Dr. Smith is a member of the Editorial
Advisory Board of the journal “Pharmaceutical Technology”. He
was the recipient of the 1998 WorldPharm Award for services to
the pharmaceutical industry.
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