Regulatory & Quality Sciences

NEW!  This Cell and Gene Therapy Trials course will examine the challenges inherent in cell and gene therapy manufacturing and clinical trials. This module is divided into four chapters and introduces fundamental concepts of these regenerative medicines, along with case studies and scenarios.

This module introduces the fundamental principles and practices involved in monitoring clinical trial sites. It covers definitions and types of clinical trials, the application of Good Clinical Practices, and the roles and responsibilities of sponsors, investigators, and institutional review boards. Learners will review essential documentation processes and quality functions such as data capture, quality control, and assurance. The module also explains the purpose and scope of trial monitoring, including the qualifications and responsibilities of monitors, data standards like ALCOA + CCEA, and the different types of monitoring activities.

This module provides a detailed understanding of the auditing process in clinical research and how it ensures compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. Learners are introduced to the distinctions between monitoring, auditing, and inspection, as well as the purpose, scope, and procedures that define an effective audit. The course outlines auditor qualifications, essential steps before, during, and after an audit, and the documentation required for evaluation, including regulatory binders and investigator credentials.

This module provides an overview of the FDA inspection process and the steps sites should take to ensure continuous readiness. Learners will explore the similarities and differences between audits and inspections, the key stages of an inspection, and the circumstances that may prompt an FDA site visit. The course emphasizes the importance of mock inspections as a tool to evaluate compliance and identify areas for improvement before an official inspection occurs.