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Recorded Webinar
A review of the FDA’s oversight, regulatory requirements and review of Warning Letter citations for Clinical Investigators
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
The FDA Investigators are tasked with regulatory oversight of clinical investigators who treat subjects with experimental drugs and devices. This program will provide a look at the 21 CFR Parts 50, 56, 312 and 320, the Compliance Program Guidance Manual section which covers the drugs, device, veterinarian, good laboratory practice inspectional guidance to investigators who are conducting the inspections. Additionally, it will review of the citations, which the Agency has written to firm’s in their Warning Letters and comments the Agency has directed at the FDA 483 responses submitted.
This presentation will provide a better understanding of what the FDA expectations are for clinical investigators, how to better document your activities, address inventory controls and does and don’ts.
Areas Covered in the Webinar:
- FDA Quality System requirements
- Compliance Program Guidance Manual review
- Review of Warning Letter citations
- What to do and not do during a clinical trial.
Who should attend
This presentation is primarily directed to Clinical Investigators and Study Coordinators who are actively involved in clinical investigations or considering starting a clinical investigation with a sponsor.
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