LIONVILLE, PA, Feburary 8, 2005 — West Pharmaceutical Services, Inc. today announced that it has appointed Debbie Thomas to the position of director of regulatory affairs, Americas. Thomas brings more than 16 years of extensive management and operational experience in regulatory compliance and quality management systems to West. Additionally, she is widely recognized by both the Food and Drug Administration (FDA) and the industry as an expert on medical gases and CGMPs (current good manufacturing practices) and their application to pharmaceutical industry suppliers.
Most recently, Thomas was director of regulatory and quality systems for Air Products and Chemicals, Inc., where she oversaw operations of the development of regulatory and quality management programs for pharmaceutical, medical device, food grade and industrial gases. She previously served as manager of regulatory and quality systems and contracts specialist/contracts administrator for Air Products and Chemicals, Inc. At West, Thomas will serve as the principal liaison with FDA and other regulatory agencies for both domestic and international regulatory issues. She will manage the submission process for all drug master files, 510k and pre-market supplements.
Her intimate understanding of the complex regulatory and compliance requirements will be especially useful to customers using West products. “Regulatory affairs is a critical element of our pharmaceutical and biotechnology customers’ development and post-market processes. It is imperative that West maintain a thorough understanding of current regulatory guidelines and assist our customers, wherever possible, in the use of West products and services,” said Fran DeGrazio, vice president, quality assurance and regulatory affairs, Americas, West Pharmaceutical Services. “West has always maintained a high standard for compliance with regulatory guidelines. Debbie’s intimate knowledge of the workings of FDA and her compliance knowledge will be invaluable to West and our customers alike.” “One of my goals at West is to continue to work closely and cooperatively with FDA towards our common goal of manufacturing safe and effective products for our customers to ensure public health safety,” said Debbie Thomas.
Thomas earned her M.A. in government and political science from Lehigh University with a concentration in FDA. She holds a degree in criminal justice from Temple University. Thomas is also a member of the Compressed Gas Association (CGA) where she is a voting member for the Medical Gases & Equipment Committee. She has also participated as a CGA member of the Guideline 2000 (G2k) Project and worked on the CGA Medical Gas Regulatory Policy Task Force. She also belongs to the Pennsylvania Association of Medical Suppliers (PAMS).
