About Us
Immel Resources LLC is a management
consulting and
publishing company specializing in regulatory compliance, quality
assurance,
and training for the pharmaceutical, biotechnology, medical device, and
related
industries. Since 1996, we have helped many organizations introduce new
products, pass major inspections, improve quality systems, and
return to compliance after regulatory
action. Clients and subscribers include global
multinational firms to small start-up companies. We are considered
quality and compliance
experts.
We work with a network of experienced consultants to meet your needs.
Publications include
the Immel
ReportTM,
a subscription newsletter providing advice and guidance for managers in
FDA-regulated industry, and our Compliance LeadershipTM reprint series. We
are based in
Petaluma, California, 45
minutes
north of the Golden Gate Bridge in the California Wine Country, and
near San Francisco
International
Airport. Thank
you for your interest in our company. We look forward to serving you.
President
Barbara K. Immel is president of Immel Resources
LLC, and editor of the Immel ReportTM. She
has 28 years of industry experience. She worked in
compliance and
training,
documentation and labeling, and corporate quality assurance
for
Syntex Corporation, Chiron Corporation, and Syva Company for more than
12
years before starting the company. She has been teaching well-respected
compliance classes for many years, including teaching CAPA and
investigations courses for nearly 10 years.
Barbara serves as conference chairperson for FDAnews'
annual FDA Inspections
Summit. She is on the steering committee and has served as chair of the
quality track for MedCon, a new medical device conference cosponsored
by
the U.S. Food and Drug
Administration and the nonprofit Xavier University. Barbara served as
the regulatory compliance
columnist with BioPharm International
Magazine for more than 10 years. She
has published more than 50 articles on a variety of industry topics in
Pharmaceutical Technology, Medical Device & Diagnostic
Industry, BioProcess International, Nutraceutical Business and Technology, Pharmaceutical
Technology Europe, and BioPharm.
She authored the Quality Assurance
of Pharmaceuticals chapter for the Dekker
Encyclopedia of Pharmaceutical Technology.
Barbara has taught
industry subjects at many companies, and at the University of
California, Berkeley;
the University of Wisconsin at Madison; the Rochester Institute of
Technology; the University of Georgia, and
Stanford University. She was elected by her peers to serve on the
national training
committees for two trade
associations, PhRMA and PDA, where she helped plan and
organize educational conferences for industry trainers for eight years.
She created and taught biotechnology courses for UC Berkeley
Extension for five years, and helped re-design the Drug Development
Course and served as co-director of the course for
several years. She
is a graduate of the Buckley School of Public Speaking, the Stanford
Professional Publishing Course, and the University of California, Santa
Barbara. Honors and awards for which we are very grateful include Who's
Who in the World, Who's Who in
America, Who's Who in American Women, Who's Who in Medicine and
Healthcare, and Who's Who in
Finance and
Business.
Publisher and Vice President
After earning his Ph.D. in biology from the
University of California at Santa Barbara (UCSB) in 1981, Joe Immel
engaged
in post-doctoral scholarship at Stanford University and the University
of California at San
Francisco (UCSF). As a postdoctoral fellow his interests centered on
the
vertebrate visual system and his research activities included
investigations in retinal morphology and physiology. In 1986, Joe
joined Axon Instruments, a manufacturer of instruments for research in
physiology and biophysics, and
as chief Technical Evangelist developed the Technical Support division
from
a single scientific liaison (Joe) to a bustling department of several
PhDs
and support staff. When a more "hands-on" approach beckoned, he
moved
to Sutter Instrument Company in 1991 where as a Research and
Development Engineer
he developed several instruments for the academic and commercial
research
community. Increasingly called upon to assist Barbara Immel in
the
growth of Immel Resources LLC, Joe moved to the position of Publisher
of the Immel Report. Today
Joe oversees day-to-day requirements of Immel
Resources
LLC from financial matters to publications.
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