Inspection Readiness for GCP – Responding to GCP Inspections

Crafting an effective response to a regulatory notification is an art that, when mastered, will help you foster a long-term relationship of trust with regulatory agencies after an inspection.  In this course, you’ll learn how to approach a notification not as a condemnation, but as an opportunity to demonstrate your organization’s dedication to quality and compliance. By following Dr. Tan and the team at CharlsGen Bio as they build their response strategy, you’ll learn about the purpose of regulatory notifications, along with the core components of a successful response, including the importance of a thorough root cause analysis (RCA) and strong corrective and preventive actions (CAPAs) in addressing findings and preventing recurrence. We’ll also explore the potential outcomes following submission and provide you with a methodical approach addressing rejected CAPA plans. By the end of this course, you’ll be equipped to develop your own response strategy, draft a professional response letter, and manage the follow-up process.