The FDA Warning Letters: Revealing the Critical Conduct Creas in Clinical Ctudies 2011
conferences > Education, Training conferences > The FDA Warning Letters: Revealing the Critical Conduct Creas in Clinical Ctudies
1 November, 2011
Palm Beach FL , USA
This 90-minute webinar will review FDA warning letters in Clinical Trials and present critical parameters to watch out for in order to secure compliance whether you are running or monitoring a clinical trial.
Whether you are a monitor or an investigator, word of an FDA inspection at your site is enough to make you wonder if everything has been done in compliance with the GCP guidelines.
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.
- Importance of correct Authority submissions & approvals.
- Achieving Protocol adherence.
Whether you are a monitor or an investigator, word of an FDA inspection at your site is enough to make you wonder if everything has been done in compliance with the GCP guidelines.
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.
- Importance of correct Authority submissions & approvals.
- Achieving Protocol adherence.
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