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Conference Directory
Clinically-Related 483's and Warning Letters: Getting through the Maze
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: california
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Clinical /Medical Operations, Clinical Quality Assurance, Clinically-Related 483's, FDA 483s for Clinical Trials, Clinical Sites, Warning Letters, FDA form 483, Clinical Sites, Sponsors
Start Date of Conference:: 12-08-2011
End Date of Conference: 12-08-2011
Description of Conference: This webinar on Clinically-Related 483's and Warning Letters will show how you can manage clinical site FDA inspections, handle issues, understand and respond to observations ("483") and/or Warning Letters.
Why Should You Attend:
FDA inspections of clinical trial sites, sponsors and IRBs have yielded observations (reported on FDA Form 483, or “483’s) and Warning Letters. Understanding the fundamentals of the FDA Biomedical Research inspections is critical in order to ensure that any observations and any subsequent regulatory action are dealt with appropriately and completely.
Areas Covered in the Seminar:
- Managing FDA inspections.
- Understanding observations.
- Providing a written response.
- Responding to observations (“483”).
- Responding to a Warning Letter.
- Dealing with the ramifications.
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 6th December 2011.
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Clinically-Related 483's and Warning Letters: Getting through the Maze
