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Preparing for Audits and Regulatory Inspections in Clinical Trials

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Description

In the highly regulated clinical research industry, compliance with Good Clinical Practice (GCP) and regulatory requirements is non-negotiable. Regulatory agencies such as the FDA (United States), and TGA (Australia) conduct inspections to ensure that clinical trials meet the highest standards of data integrity, patient safety, and ethical conduct. In addition, sponsors and Contract Research Organisations (CROs) frequently audit trial sites to assess compliance with protocol requirements, GCP guidelines, and applicable regulations.

Failing an audit or inspection can result in serious consequences, including trial delays, regulatory sanctions, financial penalties, and reputational damage. Therefore, being inspection-ready at all times is essential for clinical research professionals involved in trial management, monitoring, and site operations.

This 2-hour interactive masterclass provides a structured, step-by-step approach to preparing for regulatory inspections and audits. Attendees will gain insider knowledge, proven strategies, and real-world case studies to navigate inspections confidently, minimise compliance risks, and implement proactive quality assurance practices.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBPTM), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

Key Benefits

  • Understand Global Regulatory Expectations – Learn TGA, FDA and inspection requirements and common audit findings.
  • Achieve Audit Readiness – Develop proactive strategies to ensure continuous compliance and prepare teams effectively.
  • Minimize Compliance Risks – Identify gaps early, implement CAPA strategies, and avoid critical findings.
  • Confidently Handle Inspections – Master best practices for interviews, document requests, and regulatory responses.
  • Learn from Real-World Cases – Gain insights from actual audit scenarios and interactive expert discussions.
  • Strengthen Collaboration – Improve compliance alignment across sites, sponsors, and CROs.

What You’ll Learn:

  • Understanding ICH-GCP, FDA, EMA, and TGA inspection requirements
  • Common audit findings and how to prevent them
  • Best practices for site, sponsor, and CRO audit readiness
  • Effective CAPA (Corrective and Preventive Actions) planning
  • How to handle inspection interviews and document requests
  • Real-world case studies of regulatory compliance challenges

Who Should Attend?

  • Aspiring Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Investigators & Site Staff
  • Sponsors & CRO Teams
  • Anyone involved in clinical trial compliance & oversight

Format, Date and Time

This is a paid online event. Current Clueo Clinical IBPTM trainees: please follow the instructions provided during your onboarding.

6 April @ 2:30 pm 4:30 pm Brisbane time

Attendees will receive access link and password before the event.

$150 plus GST and Fees

Clueo Clinical

1300398806

View Organizer Website

Clueo Clinical