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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
What You’ll Learn:
Who Should Attend?
Format, Date and Time
This is a paid online event. Current Clueo Clinical IBPTM trainees: please follow the instructions provided during your onboarding.
Attendees will receive access link and password before the event.