Speaker Biographies
2008 PMF Workshop on Environmental Monitoring
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Exhibitors
Susan Schniepp
Schniepp and Associates, LLC
Susan Schniepp has over 24 years of experience in quality
assurance for both the food and pharmaceutical industries. She
began her career in 1980 as a microbiologist in the food
industry working for both Quaker Oats and M&M/Mars where she
first used the USP. In 1984 she transitioned to the
pharmaceutical industry as an R&D Microbiologist. During her
career she has had responsibilities for complaints, labeling,
test method validation and other quality systems but her primary
focus has been establishing communications with compendial
authorities. She was founder and chairman of the Midwest
Compendial Discussion Group from 1995 until 2004 when she
relocated to San Diego and founded and co-chaired the Western
Compendial Discussion Group. She has presented on USP Issues in
many venues including the PDA/FDA Joint Regulatory Conferences
from 2001-2004. In 2007 she chaired the PDA/FDA Joint
Regulatory Conference. Sue has authored several articles on
compendial matters including a book titled "Understanding the
United States Pharmacopeia-National Formulary: Demystifying the
Standards-setting Process" and is currently a Chair of a USP
Expert Committee. She has been an active participant in the
initiation and review of industry standards for many
organizations including USP, PDA, AAMI and GPhA. Ms. Schniepp
currently resides in the Boston area.
 TC
Soli, Ph.D.
Principal Consultant and President of Soli Pharma Solutions,
Inc.
Dr. T. C. Soli, Principal Consultant and President of Soli
Pharma Solutions, Inc. (SPS), has acquired considerable
knowledge of pharmaceutical water systems through his 25 years
of involvement with 5 pharmaceutical operating companies and
career-long memberships on numerous industry-wide working
committees related to water, including his current participation
in the USP Pharmaceutical Water Expert Committee.
His expertise also extends into all aspects of sterilization,
aseptic and contamination control processes and the disciplines
related to their quality control and testing, validation, and
regulatory compliance. During his career with operating
companies, he has managed personnel and processes in various
departments including microbiology and chemistry development
laboratories, QC laboratories, regulatory affairs, project
management, business development, and QA departments ranging
from validation to complaint investigation.
Using vacation time from his operating company jobs, Dr. Soli
has been consulting part-time since 1995 for small and large
pharmaceutical companies and related instrument manufacturers,
and has served as an expert witness in two litigations. He
has also conducted numerous informational and training sessions
related to pharmaceutical water microbiology and chemistry and
written numerous articles and USP chapters, including the famous
USP Informational Chapter <1231> Water for Pharmaceutical
Purposes. His consulting endeavors are now full time with
SPS.
 Tina Sturgill
Director of Microbiological Services, Celsis Laboratories
Tina is the Sr. Director of Biological Sciences for the
Celsis Analytical Services in St. Louis, MO, with focus on
microbiological testing for the pharmaceutical/ contract
industries. She has worked closely with Celsis clients to
develop and validate client methods for their products as well
as to provide microbiological support and knowledge Tina has
been with Celsis for 22 years, starting as a
bench analyst. She had also been with Invitron, a biotech fi rm
for 2 years performing QC analysis for the production group.
Tina holds a B.S. in biology with an emphasis in microbiology
from Missouri State University.
 Brenda Sullivan
Microbiology Plant Quality Manager, Hospira, Inc
Brenda Sullivan, Ph.D. is the Biological Quality Manager for
Hospira’s North Chicago Manufacturing site, formerly the
Hospital Products Division of Abbott Laboratories. Her
responsibilities include oversight and direction of the
Biological Quality Laboratories supporting the manufacture of
Aseptically Filled and Terminally Sterilized Products. Prior to
joining Hospira, she was the Microbiology Manager at CSL Behring
Pharmaceutical Company (formally ZLB Behring). Sullivan began
her career in 1986 as a Research Assistant for Rush Presbyterian
Saint Luke’s Medical Center and later received her Ph.D. in
Immunology/Microbiology in 1997
Scott Sutton
Senior Director of Microbiologic Services, Vectech
Dr. Sutton earned his Masters and PhD in Microbiology from the
University of Rochester (NY). With over 20 years of laboratory
leadership experience in the microbiology arena of the
pharmaceutical and personal products industries, he now consults
through Vectech Pharmaceutical Consultants, Inc. Clients
have included startups, generics, established Fortune 500
companies, law firms and investment broker houses. Laboratory
management, training, GMP, testing methodologies and
microbiology-related project management are areas of special
interest. He has worked with the USP Microbiology
Committee of Experts since 1993, serving as vice-chair since
2000. He operates the Pharmaceutical Microbiology
Forum with its monthly newsletter (http://www.microbiologyforum.org)
and serves as a reviewer for several peer-reviewed journals.
Dr. Sutton also operates an information source on the internet –
The Microbiology Network (http://www.microbiol.org)
that provides services to microbiology related user’s groups.
This service also supports two Email lists, the first devoted to
pharmaceutical microbiology (http://www.microbiol.org/pmflist.htm)
and the second devoted to pharmaceutical stability (http://www.microbiol.org/psdglist.htm).
Valerie Welter
Plant Quality Manager, Hospira, Inc
Valerie Welter is the Quality Operations Manager for
Hospira’s North Chicago Manufacturing site, formerly the
Hospital Products Division of Abbott Laboratories. Her
responsibilities include oversight and direction of
Manufacturing Quality, Incoming /Supplier Quality, the Chemical
and Biological Quality Laboratories, Documentation, CAPA and
Investigations and Compliance. She is responsible for management
of the quality system supporting the manufacture of large and
small volume parenterals. The product line encompasses aseptic
and terminally sterilized solutions ranging from 1ml to 1 liter
and includes lyophilized products. Prior to Quality
Operations, she held the position of Manager of Validation for
Hospira. Her responsibilities included strategic direction for
the Validation programs across domestic and international
locations including parenteral and medical device manufacturing
sites. She had primary responsibility for the development and
integration of a consistent validation program and process
across the business units of Hospira. Welter has 18 years of
experience in pharmaceutical quality assurance, pharmaceutical
manufacturing, and validation. She is a member of PDA, ISPE,
AAMI and co-chair of the Midwest Validation Discussion Group.
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