2nd GCP Inspection Readiness

2nd GCP Inspection Readiness

 December 4 to December 6, 2023 


Achieve confidence that your company is GCP inspection ready by walking through every step of the inspection preparation and execution process. Leave having heard directly rom the regulators themselves about inspection trends, what you need to implement to ensure you are prepared, and understand how technology and effective training can be utilized to drive a culture of quality, and a continued state of GCP inspection readiness.


- Discuss quality culture as the heart of any successful inspection readiness plan

- Assess current inspection risks to provide the building blocks for your GCP inspection readiness plan

- Utilize mock inspections as a quality tool to focus risk mitigation efforts

- Understand the current regulatory environment and the impact on GCP inspections

- Harness the power of the Trial Master File (TMF) to drive inspection readiness processes

- Ensure all stakeholders understand their role leading up to and during an inspection

- Leverage GCP audits to assess the inspection readiness of your clinical vendors and sites

- Outline sequence of events for managing an inspection to understand the different roles

- Recognize training as a core component to an effective inspection readiness approach.

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