BusinessEdge SolutionsÂ’ 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, ISPEÂ’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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