Course description
This practical course provides an in-depth understanding of latest GCP requirements and its practical implications as well as the insights into the current GCP inspection focus and hot topics.
The course will bring clarifications on risk-based approaches used in clinical trials, including quality tolerance limits, and how to achieve appropriate risk based monitoring and central monitoring. You will discuss what good sponsor oversight looks like and how to achive it. You will also learn about regulatory inspection results and Data integrity challenges and how to achieve inspection readiness.
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