Ms. Patricia Wood has more than 18 years of professional experience working in quality-related positions. As corporate quality assurance manager at RJLG, she is preparing the company for ISO 17025 and A2LA certification, and is responsible for attaining and maintaining various environmental accreditations. She focuses her efforts on ensuring that procedures, processes and laboratory practices at RJLGare in compliance with all of the relevant standards and regulations. Ms. Wood's career began as a bench chemist working in the pharmaceutical industry and elevated to various supervisory and management positions. She has worked in regulated industries for her entire career. In addition, she has extensive knowledge of FDA, Environmental, and various ISO standards and regulations. As the technical services supervisor for a (start up) sterile drug manufacturer, Ms. Wood was instrumental in attaining ISO certification, CE Marking, and FDA approval for various NDA and ANDAs (new drug applications and abbreviated new drug applications, respectively). As the regulatory Affairs/QA manager for a medical device manufacturer, she prepared numerous FDA submittals and successfully attained comprehensive approval for all marketed products. Also, she developed and implemented a quality system that was compliant with FDA 21 CFR 820 quality system requirements, and subsequently earned ISO 13485 certification. |