BusinessEdge Solutions’ Kate Townsend One of Two U.S. GAMP 4 Trainers
Kate Townsend has recently been appointed as a GAMP® 4 instructor for the International Society for Pharmaceutical Engineering (ISPE), making her one of two such instructors in the United States and the fifth instructor worldwide to teach several hundred pharmaceutical professionals yearly about the GAMP 4 approach to the validation of automated systems.
EAST BRUNSWICK, NJ (PRWEB) March 27, 2005 -- It is no small honor to be one
of five experts in the world who are able to train others in a given skill. Kate
Townsend, a solutions partner with a focus on value-based compliance management
at BusinessEdge Solutions Inc., an integrated, industry-focused consulting firm
serving the life sciences industry, falls into this category. Ms. Townsend has
recently been appointed as a GAMP® 4 instructor for the International Society
for Pharmaceutical Engineering (ISPE), making her one of two such instructors in
the United States and the fifth instructor worldwide to teach several hundred
pharmaceutical professionals yearly about the GAMP 4 approach to the validation
of automated systems. GAMP 4 is an acronym for Good Automated Manufacturing
Practice.
In this role, Ms. Townsend trains pharmaceutical professionals
in achieving validated and compliant computer systems that meet current health
care regulatory standards, according to Donna Catalini, ISPE’s director of
training. ISPE is a global not-for profit membership organization that provides
education, training and technical publications to more than 20,000
pharmaceutical manufacturing professionals worldwide.
Ms. Townsend was
recommended for this position by Sion Wyn, director of Conformity, a
pharmaceutical consultancy in the United Kingdom. “Kate is well-qualified for
this role because of her subject matter expertise, her excellent training and
presentation skills, and her commitment to best practices in regulatory
compliance,” said Mr. Wyn, who also serves as technical advisor to ISPE,
considered the foremost international source of guidance on computer systems
validation and compliance.
GAMP was founded in 1991 by a core of
pharmaceutical experts in the United Kingdom who were interested in evolving
regulatory expectations for automated systems supporting manufacturing
processes. GAMP quickly became influential throughout Europe as the quality of
its work was recognized. In 1994, GAMP partnered with ISPE to publish the first
GAMP guide and to run training seminars, and, in 2000, GAMP Americas was
founded.
Ms. Townsend, a veteran instructor in computer systems
validation, taught her first GAMP 4 training seminar earlier this month,
instructing a group of professionals from major life sciences companies as well
as life science vendors and consultants – all who received a certificate and the
option for continuing education credits. She will teach a course on 21 CFR Part
11, the FDA regulation for electronic records and electronic signatures, and a
more advanced course in computer systems validation later in the year.
Ms. Townsend, who has more than 18 years of experience supporting the
life sciences industry, demonstrates an in-depth knowledge of FDA and
international regulations. Her recent publications include “Understanding and
Implementing A Risk-Based Approach to 21 CFR 11 Compliance,” which was published
in the July 2003 issue of Pharmaceutical Technology.
A recognized
industry leader in computer systems compliance, Ms. Townsend has presented to
senior executives at many leading pharmaceutical companies on industry and
regulatory trends in computer compliance, as well as presenting at industry
meetings.
She spent her early career at Sterling Winthrop, an
international pharmaceutical company. As a manager within the information
systems organization, she was responsible for the implementation and validation
of computer systems in the United Kingdom, France and the United States. She
holds a Bachelors degree in Computer Studies and a Masters degree in Engineering
from Lancaster University in the United Kingdom.
“Kate’s appointment to
such a select group of professionals is a well-deserved acknowledgement of both
her expertise and her dedication to developing best practices within the life
sciences industry,” said Shailendra Jain, managing partner at BusinessEdge
Solutions. “Her work as an instructor will surely benefit those whose roles
require them to learn more about regulatory compliance issues, especially in the
field of computer systems validation.”
Ms. Townsend’s recent class would
surely agree. Said ISPE’s Ms. Catalini: “Kate received high marks from her
students.”
International Society for Pharmaceutical Engineering
ISPE,
the International Society for Pharmaceutical Engineering, is a global,
not-for-profit membership organization that provides education, training, and
technical publications to pharmaceutical manufacturing professionals. Based in
Tampa, Florida, ISPE is committed to the advancement of the educational and
technical efficiency of its members through forums for the exchange of ideas and
practical experience. The GAMP / ISPE partnership has become the acknowledged
expert body concerning computer validation issues.
About BusinessEdge
Solutions Inc.
BusinessEdge Solutions is an industry-focused consulting and
integration firm that serves the life sciences, communications and financial
services / insurance industries. The company leverages innovative Reusable
Solution Accelerators (RSAs) to reduce the time, cost and risk of client
engagements. BusinessEdge is distinctive among consulting firms in that its
multidisciplinary consultants have an average of 12 years of industry
experience. Focusing on value chain performance, the BusinessEdge life science
practice helps clients develop competitive advantage in product development
acceleration, rapid commercialization, marketing and sales effectiveness, and
value-based compliance management. For more information, please visit www.businessedge.com.
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Source : http://www.prweb.com/releases/2005/3/prweb222088.htm