GCP/ICH INSPECTIONS

Service Description

Learning Objectives By the end of this course, participants will be able to: - Understand the key principles of ICH GCP (E6 R3) and their application to inspection readiness. - Identify common inspection findings and proactive measures to mitigate them. - Develop and implement an inspection readiness plan, including mock audits and team coordination. - Navigate the inspection process, from preparation to follow-up, with confidence. Key Topics Covered 1. Introduction to GCP/ICH Framework (45 minutes): Overview of ICH E6(R3) updates, regulatory expectations, and the role of inspections in clinical trials. 2. Risk Assessment and Readiness Planning (60 minutes): Identifying high-risk areas, conducting gap analyses, and building a robust inspection readiness checklist. 3. Documentation and Data Integrity (45 minutes): Best practices for maintaining essential documents, ensuring ALCOA+ principles, and handling electronic records. 4. Managing the Inspection Process (60 minutes): Strategies for hosting inspectors, responding to queries, and addressing findings; includes interactive role-playing. 5. Post-Inspection Follow-Up and Lessons Learned (30 minutes): CAPA development, continuous improvement, and case studies of real inspections. Delivery Format Delivered virtually or in-person with a mix of lectures, interactive exercises, and Q&A sessions. No prior certification required; materials include a participant workbook, checklists, and access to online resources for ongoing reference. Target Audience This course is ideal for clinical research professionals, including investigators, study coordinators, monitors (CRAs), quality assurance personnel, sponsors, and regulatory affairs staff involved in clinical trials. It is suitable for those new to inspections or seeking a refresher on best practices aligned with ICH E6(R3) guidelines. Benefits Attendees will leave with actionable tools to enhance their organization's inspection preparedness, reduce compliance risks, and foster a culture of quality in clinical research. This training supports professional development and aligns with industry standards for GCP certification renewal. Date: APRIL 14th, 2026