The 2010 FDA warning letters: Revealing the critical conduct areas in clinical studies (Clinical Training)

Venue: Online Event

Location: Online Event,Palo Alto, California, United States

Event Date/Time: Nov 01, 2011 End Date/Time: Nov 01, 2011
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This presentation will provide a cumulative review of the FDA warning letters of 2010 and help you identify the key conduct areas in clinical trials. When clustered, the findings that most frequently appear in warning letters are a measure of the severity of non compliance. We will show critical parameters to watch out for in order to secure compliance whether you are running or monitoring a clinical trial.

By attending this webinar, you can identify and take control of areas that are usually prone to non-compliance and apply early, preventive action to secure your site or your study.

Areas Covered in the Seminar:

- Official definition of GCP and its importance.
- Statistics: Frequency of appearance of deficiencies in the FDA warning letters of 2010.
- What the statistics of warning letters reveal as critical conduct areas.
- Common ranking of findings: minor-major-critical.
- Overview of the key conduct areas.
- Cases, analysis of deficiencies and CAPAs.
- ICH guidelines on the Informed consent process.
- Management of investigational drug.
- Investigator site file and essential documents.
- Source data capture in clinical trials.
- Site and people management.


Online Event
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