Masterclass: Preparing for Audits and Regulatory Inspections in Clinical Trials

Masterclass: Preparing for Audits and Regulatory Inspections in Clinical Trials

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.

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?

🔹 Clinical Research Associates (CRAs)
🔹 Clinical Research Coordinators (CRCs)
🔹 Clinical Investigators & Site Staff
🔹 Regulatory Affairs & Quality Assurance Professionals
🔹 Sponsors & CRO Teams
🔹 Anyone involved in clinical trial compliance & oversight

📅 Date: 6 April 2025
📍 Format: Live Virtual Masterclass. This online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.
⏳ Time: 2:30 pm AEST – 4:30 pm AEST
💰 Cost: $150 + GST

📃Certification:  Each attendee will receive a certificate of completion to boost your CV and enhance your employability.

🎯 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.

👩‍🎓 IBP trainees: Please use the discount code provided during registering.

✨ Early Bird Discount: Save 20% when you register before 28 March 2025!
✨ Group Discount: Enrol with 2 or more colleagues and save 30%!

📢 Referral Bonus!

Share this event with your network! For every friend or colleague you refer who registers, you’ll receive an addition 10% discount on your own ticket! Plus, the person you refer will get a 10% special discount too!