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About CSI
Recognizing a critical need in the pharmaceutical and biotech industry to supply expertise in the area of FDA compliance, CSI was formed in 2004. CSI's strength lies in its 60 years combined experience integrating computer science with pharmaceutical science. CSI's principal consultants are committed to using their knowledge base to ensure project quality and customer satisfaction.
Pharmaceutical, biotechnology and medical device industries must meet increased government regulation in the global market place. Success in the drug and medical device industries depends on accelerating the development and clinical testing process while meeting the quality standards for licensure and registration. Automated computer systems are essential to realizing this acceleration and must comply with (U.S. 21 CFR Part 11) regulations as well as validation standards. By utilizing the expertise at COMPLIANT SYSTEMS INTEGRATION, INC., companies can raise the performance bar, improve new product cycle times and achieve quality compliance necessary for successful licensure.
Meet the Team
Dr. Sally Quataert
Sally A. Quataert, Ph.D. has over 20 years experience in the medical diagnostics and biopharmaceutical (vaccine) industries. She received a Masters’ and Doctorate degrees in Microbiology and Immunology from the University of Buffalo at Buffalo, New York. She has been responsible for developing several monoclonal antibody facilities, and bioanalytical laboratories for various companies including Wyeth, Lederle-Praxis Biologics, Electronucleonics and Corning. At Wyeth, her lab developed and performed pre-clinical testing for the characterization and release of clinical trial material. She has managed technical transfers and set up of QC laboratories for multiple vaccine projects. While at Wyeth she was part of the business process quality management team that re-designed how Wyeth Vaccines set new product release specifications. She was an integral part of the team that implemented this process for Prev(e)nar and Menigitec vaccines prior to licensure in 1998 and 2000. Most recently Sally has led the transformation of Wyeth Vaccines central clinical and pre-clinical testing laboratories into a GLP plus compliant organization, strategically positioning the bioanalytical services to meet increasingly stringent regulatory standards for biopharmaceuticals.
Janice Skuse
Janice Skuse has 20 years experience in bioanalytical lab, outsourcing, and data management, automation and process development, and cGCP compliance. She earned her SUNY A.A.S. and bachelor's degrees in medical technology and biology, respectively. She has managed technical transfers of bioanalytical methods and equipment, and qualification of laboratories in the U.S. and Europe. She has led multiple process development teams resulting in laboratory efficiency improvements meeting clinical testing demands per schedule for licensure of several new vaccine products.
She has experience working in clinical laboratories and data management and has worked for Wyeth for the last 18 years. Her work experience includes detail oriented process design, efficiency improvements, laboratory operations and robotic automation, implementation and training program design.
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