A Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trial. FDA requirements regarding GCP and related inspections have been around for decades. Despite this, GCP deficiencies are still a major reason for FDA rejection of clinical study data or other regulatory action. Often, simple proactive steps can be taken to strengthen your GCP program and help you survive these inspections. This interactive, 90-minute online course will provide you with the tools to safeguard against inspection deficiencies and satisfy regulatory agencies that your efforts are compliant.
By attending this course, you will learn:
- Tips and tricks to prepare for – and survive – a FDA GCP inspection
- The top issues inspectors see…and how to avoid them
- Knowledge of the most common outcomes and findings
- How to detect problems and deal with them before the inspection
- How to respond to inspection findings and avoid further regulatory action
- Communicating with the FDA – what to say, when to say it, and when to say nothing