Clinical Trials : Preparing for an audit or an inspection

Whether you represent investigatory sites, or sponsor or CRO sites, it’s important to prepare for GCP inspection beforehand. Understanding how GCP audits and inspections are performed can make the process easier. As always, the best way to pass GCP inspections is to ensure GCP compliance with relevant regulatory requirements of that region. In the following lessons, we’ve covered in-depth review of inspection processes of different sites which can serve as a guiding tool to understand regulatory processes in GCP inspection.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Lesson 1: Introduction

Lesson 2: Preparing for a GCP Inspection

Lesson 3: GCP Regulatory Inspection of Sponsor and CRO Sites

Lesson 4: GCP Inspection of Investigatory Sites

Lesson 5: Post-Inspection Activities

Conclusion

Glossary

Evaluation