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Ms. Wistar’s experience in quality assurance management and qualifications as Lead Auditor and ASQ-certified Quality Auditor will be beneficial to our clients designing and implementing quality management systems for medical device and diagnostics products.
ROCHELLE, Va. (PRWEB)
July 15, 2021
NDA Partners President Earle Martin announced today that Shelley Wistar, former Senior Manager of Global Quality Systems at Illumina, has joined the firm as an Expert Consultant. Ms. Wistar is a quality assurance professional with more than 33 years of experience in ISO 13485:2016 quality management systems, auditing and gap remediation, quality planning and process improvement, quality management system training, and application of quality systems to Phase 1 drug development. She is an Exemplar Global ISO 13485:2016 certified Lead Auditor and ASQ-certified Quality Auditor.
In addition to her role at Illumina, Ms. Wistar was Manager of Regulatory Affairs, Quality Management, and Compliance at Becton Dickinson Diagnostics (GeneOhm), Compliance Manager at InVivoScribe Technologies and Biosite, and served in quality assurance roles at Gen-Probe and Becton Dickinson Advanced Diagnostics. In her early career, she was a research aide in the Department of Microbiology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.
According to Ms. Deb Koeneman, Manager of NDA Partners’ medical device practice, “Ms. Wistar’s experience in quality assurance management and qualifications as Lead Auditor and ASQ-certified Quality Auditor will be beneficial to our clients designing and implementing quality management systems for medical device and diagnostics products. We are pleased to welcome her to NDA Partners.”
Ms. Wistar received her bachelor’s degree in nutrition and dietetics from the University of Maryland and a certificate for Quality Assurance/Control for the Drugs and Biologics Industry from the University of California, San Diego. Ms. Wistar is a member of the American Society for Quality.
About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Contact
Earle Martin, President
Office: 540-738-2550
MartinEarle@ndapartners.com
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