Live Webinar

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.

   06 February 2026    |       11.00 AM Eastern Time (US/Canada)    |       04.00 PM GMT    |       90 Minutes    |       FDB3665

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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.
    Charles H. Paul    |         60 Minutes    |       FDB3665
 

Registration to this course includes:

  • Presentation Handout & Templates
  • Certificate of Completion
  • Trial access to TalkFDA Subscription
  • TalkFDA Members-only Community

LIVE - SINGLE

US $290
ONE participant (viewer) – Live session
PLUS Complimentary Streaming access for 2 month

CORPORATE - LIVE

US $990
Up to 10 participants – Live session
PLUS Complimentary Streaming access for 2 months for each attendee

TalkFDA Membership Benefits

Be a part of the exclusive community
Explore how membership complements your learning

Registration to this course includes:

  • Presentation Handout & Templates
  • Certificate of Completion
  • Trial access to TalkFDA Subscription
  • TalkFDA Members-only Community

SINGLE ACCESS

US $290
ONE participant (viewer) – Streaming access for 2 month

CORPORATE ACCESS

US $990
Up to 10 participants – Streaming access for 2 months for each attendee

TalkFDA Membership Benefits

Be a part of the exclusive community
Explore how membership complements your learning

Why take this course?

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.

  • Regulatory confidence under pressure:

    GCP inspections test more than procedures — they test consistency. This course helps professionals recognize how inspectors think, what evidence they expect, and where organizations often lose credibility. By aligning quality systems, documentation, and oversight, participants gain confidence that decisions made during trials can be explained, defended, and supported without hesitation when scrutiny is highest.


  • Stronger systems, fewer surprises:

    Audit findings often trace back to weak internal checks. This session reinforces how to structure internal audits, SOPs, and documentation so issues surface early, not during inspections. The result is less reactive firefighting and more predictable outcomes — a critical advantage in clinical environments where delays, findings, or rework can derail timelines and trust.

  • People who are inspection-ready, not just trained:

    Training alone doesn’t equal readiness. This course highlights how roles, accountability, and continuous education shape inspection outcomes. When staff understand expectations and their part in compliance, inspections become manageable events instead of organizational stress tests.

Key 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
If you would like to request a Proforma invoice to sign up for this course. please click here

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