“Insights of a FDA Medical Device Inspection”
Attendees will come away with these three takeaways:
- A Case for quality – It is all about Safety and Efficacy.
- How to prepare and what to expect during your FDA inspection.
- The good (NAI), the not so good (VAI), and the not good (OAI) inspection.
Donna T. Besone, Investigator / CSO (Medical Device)
Donna Tartaglino Besone is a Medical Device Specialist with the U.S. Food and Drug Administration. She joined the FDA in 2002, and has since conducted more than 100 inspections of medical device manufacturers (domestic and international), including inspections and investigations covering clinical studies, premarket approval, in-vitro diagnostic, and combination products (devices/human tissue/drugs). She came to the FDA with more than twenty years of experience in research, process engineering, computerized and manual manufacturing operations, and general management positions.
Ms. Tartaglino Besone became a Level II FDA Certified Medical Device Investigator in 2014 and a Medical Device Specialist in 2015.
Ms. Tartaglino Besone obtained a Bachelor of Science in Chemistry and Master’s in Engineering from the University of California at Irvine and a Master’s of Business Administration from Pepperdine University.
Janet Pulver, Investigator / CSO (Medical Device & Radiology)
Janet Pulver is a Medical Device Specialist with the U.S. Food and Drug Administration. She joined the FDA in 2008, and has since conducted more than 100 inspections of medical device manufacturers (domestic and international), including inspections covering human tissue and Radiological Health regulations. She came to the FDA with more than twelve years of experience in FDA-regulated industry, working in clinical research and manufacture of medical devices and human tissue products, primarily in Quality Assurance and Regulatory Affairs positions. Prior to that, she spent eight years as a Medical Technologist working with In Vitro Diagnostic (IVD) devices.
Ms. Pulver became a Level II FDA Certified Medical Device Investigator in 2011 and a Medical Device Specialist in 2012. She has attained Certifications from the Association for Quality (Certified Quality Auditor), Regulatory Affairs Professionals Society (Regulatory Affairs Certification), RABQSA International (Quality Management Auditor), and the American Association for Tissue Banks (Certified Tissue Bank Specialist). Ms. Pulver is also an Instructor for the FDA’s national Core Medical Device Course, and a subject matter expert for the Regulatory Affairs Professionals Society’s Online University.
Ms. Pulver obtained a Bachelor of Science in Natural Sciences from the University of Puerto Rico, and a Master’s of Science in Administration from Central Michigan University.
Note: Location and Speakers are subject to change based on availability
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- Bring your printed ticket or electronic ticket. See details below.
- A government issued photo ID that matches your event registration.
- ASQ Member ID (Required if registered as an ASQ Member)
- All posted facility signs and directions must be followed for security reasons. Failure to follow them will result in dismissal from the event site.