GMP Training Systems, Inc.
David Markovitz, Founder and President, GMP Training Systems,
Inc.
and creator of the GMP Training System™
Experience you can trust! With over three
decades experience in the Life Sciences industry, David
knows what it takes to keep your operation in Compliance with FDA
regulations. Helping Life Science professionals make GMP a Lifestyle
in their respective companies is the mission of GMP Training Systems,
Inc., which David started in 1996 after twenty years of corporate
leadership experience in the FDA regulated industry. After conducting GMP and QSR workshops for over 100 companies,
David has created the
GMP Training System™
for use by your internal trainers, supervisors, and leads. As a former
Corporate Director of Education and Training, Production Manager and
Production Supervisor, David knows how to design training that works and
has an impact. David has traveled the world helping people in the FDA regulated
industries understand their responsibility to their customers, to their
company, and to the regulatory agencies, specifically the Food and Drug
Administration (FDA). In addition, David has assembled a team
of highly qualified experts to ensure that you receive the highest
quality consulting and training in a wide range of FDA compliance
topics. David is also the Co-Founder and President of the
Institute for Effective
Innovation, a company created to help people in companies and
organizations improve their Innovation Instinct™,
which is the ability to generate valuable ideas, build on
them, and implement them.
Expert Consultants/Faculty
David Markovitz
has over three
decades of leadership and management experience in the FDA regulated
industries. Having held positions as Manufacturing Laboratory Manager,
Packaging and Filling Manager, Pilot Plant Manager, Manufacturing
Engineer, Technical Training Manager, and Corporate Director of
Education and Training, he has hands-on experience in effectively
managing complexity with limited resources. David’s corporate
experience was acquired at Nutrilite Products, SmithKline Beckman,
Organon Diagnostics, and Ortho Diagnostics.
David had the
rare privilege of assisting Dr. W. Edwards Deming, the 20th
century’s leading quality guru, in several of his famed Four-Day
Seminars. David created and led the Deming Roundtable, an intensive
year-long cooperative effort involving eight different organizations
working to implement Deming’s teachings. An internationally
recognized and award winning speaker and workshop leader, David has been
invited to present at conferences and meetings throughout the world. He
is the recipient of the Gold Microphone Award (National Speakers
Association) and the 2004 winner of the prestigious Connie Award for
Professionalism on the Speaking Platform.
Gamal Amer
Ph.D.
is
Principal at Premier Compliance Services, Inc.; Management Consultants
for compliance and manufacturing operations performance in the life
sciences industry. He holds a Ph. D. in Chemical Engineering and has
over two decades experience in the Pharmaceutical and related
industries. He has held positions of increased responsibility with
leading pharmaceutical, consumer product and engineering consulting
firms over the years. His experience includes comprehensive process
design in bulk pharmaceutical manufacturing, biotechnology
manufacturing, pharmaceutical solid dosage manufacturing and containment
of potent and radioactive therapeutics. He is also experienced with
facility development for therapeutic products operations. Dr. Amer has
consulted for many of the leading pharmaceutical, biotechnology and
medical device manufacturers. He has lectured extensively in the US,
Europe, Asia and the Middle East, taught many courses, and authored many
papers which were published in peer reviewed publication.
Lynda Curtin
is known as The
Opportunity Thinker. She is President of deBono for Business and
is an expert practitioner of world renowned de Bono
Thinking Systems methods — the most powerful, proven and practical
creativity and innovation tools available anywhere. Her extensive
business background in a broad range of industries — product manager
responsible for managing a variety of product lines from $20.0 million
to over $100.0 million in sales connects with clients — she understands
the fast pace of work having thrived on the firing line everyday for 18
years to deliver hefty sales and profit goals in the midst of rapid and
revolutionary change. Lynda is well equipped to help clients tackle
their business challenges with fresh new thinking. She has
conducted workshops around the world for clients, including Hewlett
Packard and Astra Zeneca.
John Dolan
Ph.D.
is most widely known as the author of
LC/GC’s popular LC Troubleshooting column. As editor of this
column for over 20 years, Dr. Dolan has contributed more than 250
installments of practical advice to practicing chromatographers. John has
written over 100 technical papers, many of which support the development and
practical application of gradient elution LC. His books (with Lloyd Snyder),
Troubleshooting LC Systems and
High-Performance Gradient Elution, are standard references in
laboratories worldwide. Dr. Dolan managed a regional contract research
laboratory for 11 years for LC Resources and later Bioanalytical Systems,
Inc. The lab, which he helped found in 1988, specializes in the development,
validation, and application of LC-MS/MS methods to determine pharmaceutical
compounds in biological matrices. In addition, he is one of the founders of
LC Resources, Inc., a company dedicated to training chromatographers around
the world. As an instructor for LCR and the American Chemical Society, John
has instructed more than 10,000 students in practical LC techniques.
Jim Gerner
Ed.D., M.S., M.T.(ASCP)
has
over two decades experience as a consultant in the Pharmaceutical,
Medical Device, and Food Industries and in a corporate manufacturing
environment. Dr. Gerner is a registered Medical Technologist - M.T. (ASCP),
and his education includes a B.A. in Medical Technology, M.S. in
Curriculum and Instruction, an M.S. degree in Clinical Microbiology, and
a doctorate degree, Ed.D., in Corporate Training and Development.
Tom
Jupille
is President of LC Resources, a Consulting Editor for
LCGC, and associate director of the California Separation Science
Society (CASSS). Tom is the founder and moderator of Chromatography Forum,
an on-line discussion group focused on providing practical support to
practicing chromatographers.
He has
been a practicing chromatographer for more than 30 years, during which he
has written more than 30 papers on chromatography and related subjects. He
worked primarily in gas chromatography in the late ‘60s, switching to
thin-layer chromatography in the early ‘70s and then to HPLC and ion
chromatography in the late ‘70s. Over the past 20 years, Tom Jupille has
presented courses and seminars in the field of chromatography to more
than 5000 students. In addition to teaching, he has been involved in the
development and support of computer modeling techniques for
chromatography method development.
Carmen Medina
is President of Precision Consultants, Inc. and is a
former FDA
investigator and a leading thinker in the field of Pharmaceutical
Compliance and Quality Assurance. She is an international consultant
with extensive experience in the medical device, pharmaceutical, and
biotech industries. Ms. Medina was a Commissioned Officer in the United
States Public Health Service from 1986 to 1992 during which time she
served as a Field Investigator for the U.S. Food & Drug Administration,
specializing in pre-approval inspections. Her experience includes being
Director of Regulatory Affairs and Product Development at Ivax Corp.
Having worked on both sides of the industry, the regulator and the
regulated, Ms. Medina has a unique understanding of what it takes to be
compliant. In addition, she is a Professor of “Advanced Quality
Assurance for Biotechnology” at the University of California, San Diego.
Shib
Mookherjea
Ph.D.
has
has a proven track
record in problem solving and extensive accomplishments in the areas of
pharmaceutical development, marketing, quality assurance, quality
control, process upgrade, analytical support for stability studies,
environmental studies, worker exposure (OSHA), and validation in the
laboratory. He has held senior scientist and management positions with
multinational organizations, including Colgate Palmolive, Johnson &
Johnson, Troy Corporation, BASF, and several academic institutions.
Miguel Montalvo
is the President of Expert Validation Consulting, Inc.
Before forming EVC, he was a Vice-President for AAC Consulting Group
where he directed the business unit for the Validation Compliance Group
at AAC, providing specialized compliance-focused consulting and
management of validation projects for customers around the world.
Previously, Mr. Montalvo held positions of increasing responsibility in
the areas of Validation, Technical Services and Quality Operations for
Millipore Corporation, Raytheon Engineers and Constructors, Mova
Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare
Corporation. Miguel has assisted pharmaceutical, biotechnology, OTC and
medical device firms in the areas of validation and quality systems for
over two decades.
Steven Walfish
is President of
Statistical Outsourcing Services and brings close to two decades of
industrial experience providing statistical solutions to complex
business problems. He was Senior Manager Biostatistics, Nonclinical at
Human Genome Sciences in Rockville MD. Steven has held positions with
PricewaterhouseCoopers, Chiron Diagnostics and Johnson &
Johnson. He holds a Bachelors of Arts in Statistics from the University
of Buffalo, Masters of Science in Statistics from Rutgers University and
an Executive MBA from Boston University.
Click here to see a list of the clients who have
used GMP Training Systems, Inc. to conduct
training for their people.
Click here to learn how we can provide
training specifically for your
company.
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