Insight Into Medical Device Inspections From The US FDA
$0 – $40
Insight Into Medical Device Inspections From The US FDA

Insight Into Medical Device Inspections From The US FDA

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Peacock Gardens Cuisine of India & Banquet Hall

23347 Golden Springs Drive

Diamond Bar, CA 91765

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“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.

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FDA Speakers:

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.


Note: Location and Speakers are subject to change based on availability

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Important Attendee Information:

  • 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.
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Date and Time

Location

Peacock Gardens Cuisine of India & Banquet Hall

23347 Golden Springs Drive

Diamond Bar, CA 91765

View Map

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