This course provides a full-spectrum exploration of GLP and GCP, the internationally recognized quality systems that underpin non-clinical and clinical research.
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Good Laboratory Practices (GLP), codified in 21 CFR Part 58 and OECD guidelines, ensure the integrity, reliability, and reproducibility of non-clinical safety data used to support product approvals.
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Good Clinical Practices (GCP), defined by ICH E6(R2) and FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, and 812), safeguard human subject rights, data integrity, and ethical trial conduct.
Participants learn how to design, execute, monitor, and audit research programs that meet U.S. FDA, OECD, and ICH standards, and how to integrate quality systems, data management, and risk-based oversight into every stage of product development.
The course is ideal for principal investigators, QA/QC specialists, study directors, clinical research associates, regulatory affairs professionals, laboratory managers, and attorneys supporting life-science R&D.
Course Objectives
By the end of the course, participants will be able to:
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Interpret and apply GLP and GCP regulations across non-clinical safety studies and clinical trials.
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Design and maintain compliant quality systems, including SOPs, training programs, and data integrity controls.
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Plan and oversee non-clinical studies and clinical trials with rigorous documentation, risk management, and monitoring.
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Identify and mitigate compliance risks, including protocol deviations, data manipulation, and informed consent failures.
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Respond effectively to inspections and audits by FDA, EMA, OECD member authorities, and other regulators.
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Anticipate and adapt to emerging trends, such as decentralized trials, electronic data capture, and AI-assisted research.
