ICH E6

Inspection Readiness for GCP – Hosting GCP Sponsor Inspections

Consider two companies: one aces their regulatory inspection and joyfully celebrates a successful application to market their drug. The other faces years of delay due to overlooked deficiencies. As a Sponsor, which path would you choose for your company? It takes a significant amount of time and effort to get a new drug to patients, but success hinges on more than just scientific innovation. A proactive approach maximizes the likelihood of a positive outcome. We’ll go through a company’s successful inspection process, from the initial planning and team formation to managing inspector requests, daily debriefs and leveraging post-inspection insights. In this course, you’ll discover strategies that put your company on the path to continuous improvement, patient safety, and marketing approval.

CEU Credits: 0.1
Course Code: ELM-956
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 07/31/2025

Curriculum for this course

A Tale of Two Sponsors
Designing the Inspection Hosting Process
Process Components
Assigning Inspection Roles and Responsibilities
Forming the Team
Communication Planning
Inspection Logistics
Stakeholder Training
You’re the Inspection Consultant!
Greeting the Inspector
Fulfilling Inspection Requests
Defining the Document Flow Process
When the Request is for an Interview
Daily Inspector Debrief
Daily Debrief and Course Corrections
Post-Inspection Follow-Up
Test your Knowledge!
v1.0 Course released on 10/28/2025

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