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.
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