The 2010 FDA warning letters: Revealing the critical conduct areas in clinical studies (Clinical Training)
Venue: Online Event
|Event Date/Time: Nov 01, 2011||End Date/Time: Nov 01, 2011|
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.