This course sharpens GCP audit and inspection readiness by turning quality systems, documentation, and training into defensible proof of compliance that regulators trust when trial integrity is under review.
GCP audits and inspections don’t fail because teams don’t care — they fail because systems, documentation, and training don’t hold together under pressure. When regulators arrive, they aren’t looking for effort. They’re looking for proof. Proof that ethical standards are embedded, records are reliable, deviations are understood, and oversight is real. That level of readiness doesn’t happen at the last minute.
This webinar focuses on building inspection readiness into daily clinical operations, not treating it as a once-a-year scramble. It connects GCP principles to real execution: how quality systems support trials, how SOPs actually protect data and subjects, and how documentation tells a coherent story from protocol to final report. The emphasis stays practical — what inspectors examine, where organizations commonly slip, and how gaps quietly form long before an audit is announced.
The session also addresses the human side of readiness. Internal audits that work, training that sticks, and accountability that doesn’t vanish after onboarding. The goal is simple: fewer surprises, cleaner inspections, and a clinical operation that can defend its decisions with confidence. For anyone responsible for trial quality, compliance, or oversight, this is about staying in control when scrutiny is highest.
Areas Covered:
Core GCP principles and ethical responsibilities in clinical trials
Regulatory expectations aligned with ICH E6 (R2) Good Clinical Practice
Building inspection-ready QMS, SOPs, and documentation frameworks
Designing and executing effective internal GCP audits
Managing inspection findings, observations, and corrective actions
Personnel training models that sustain compliance over time
Common inspection pitfalls and how regulators identify them
Inspection readiness practices tied to 21 CFR Parts 312 and 812
Course Director
What Happens After You Register
FDB3665
© All rights reserved