Skip to main content

2018 AM: N-3 - GCP Risk-Based Audit Program Planning

2018 AM: N-3 - GCP Risk-Based Audit Program Planning
N-3 – 17 minutes


Risk-Based Audit Program Planning: GCP System Audits



Liziel Concepcion, Allergan



The goal of system audits is to establish that core clinical research processes are compliant with ICH guidelines, applicable local regulations and company policies and procedures, regardless of the priority level of the research being conducted. System audits allow an organization to leverage risk across all therapeutic areas and research activity without having to touch every trial at any given time. A risk-based approach is more likely to ensure subject protection and overall study data integrity and allows sponsors to focus compliance efforts more efficiently. In this session, we will cover quality risk management concepts and explore ways to implement these concepts utilizing a risk-based approach for a GCP system audit program/plan.

Discounted member price: 20.00
30.00
You could save: 33%