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Recorded Webinar
FDA Medical Device Warning Letter Trends and Prevention
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
An FDA WarningLetter is an action taken by FDA to document the existence of significant deficiencies related to operations at a facility. Sometimes this means that a foreign manufacturer is not able to ship their products to the United States.
Areas Covered in the Webinar:
- What are the current roles of the USFDA to ensure that medical devices are not adulterated or misbranded?
- The FDA Foreign and Domestic Manufacturer Inspections and enforcement methods will also be discussed in order to facilitate these companies in understanding FDA’s approach to ensuring global compliance for medical products marketed, sold, and distributed within the United States.
- Current FDA-483, Inspectional Observations, will be discussed and the top citations for medical device manufacturers will be presented. These FDA observational findings can be directly related to current Quality System problem areas for medical device manufacturers which need to be assessed, addressed, and corrected in order to be in substantial compliance with FDA.
- FDA WarningLetter prevention will also be presented associated with 8 areas which need attention in order to ensure a compliant Quality System related to current FDA regulations and laws.
- Understanding what steps should be taken in order to ensure a robust system will also help ensure that your products are approved for and able to be commercially distributed within the United States.
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