WEBINAR INSTANT STREAMING ACCESS

Good Clinical Practices (GCP) Audit and Inspection Readiness

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

Charles H. Paul
Charles H. Paul brings more than 30 years of hands-on regulatory and compliance experience supporting clinical and regulated organizations worldwide. Known for clear thinking and practical execution, he helps teams translate complex GCP expectations into systems that hold up during audits, inspections, and real-world regulatory scrutiny.

What Happens After You Register

Once registered, the process is fully coordinated by our events team.
  • Onboarding/Welcome is sent by email
  • Login info is shared a day in advance, so you’re set before the session
  • Handouts and materials (where applicable) are shared before start
  • The session is instructor-led via Webex
  • The session includes live participation and Q&A
  • Certificates of completion are issued after the training
  • If you select live + recording, post-session access is provided via our learning environment – TalkFDA
  • Event support is available throughout for any access or logistics needs
  • After completing your purchase, access is provided in a structured and supported format.

  • Onboarding/Welcome is sent by email with next steps
  • The full session recording is made available through our learning environment – TalkFDA
  • Access is available shortly after purchase, so you can begin without delay
  • Recording access includes the complete presentation and instructor-led discussion
  • Certificates of completion are issued upon course completion
  • Support is available for any access or technical assistance
  • Your Learning Environment
    This training is delivered within a professionally managed learning environment.

  • Many organizations rely on this structure to support repeatable, audit-ready learning
  • Sessions are developed and led by experienced industry practitioners
  • Delivery and access are supported through a structured digital system, not ad-hoc file sharing
  • Where applicable, post-session access is managed through TalkFDA, our learning environment
  • This approach ensures consistency, continuity, and traceability across trainings
  • FDB3665

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