Risk-based principles and quality management systems are the new reality of clinical auditing. Building on their foundation of traditional auditing techniques, auditors must now expand and adapt their skills to be effective in this new environment. As risk-based monitoring continues to increase along with the development of quality risk management, the need for integration of these two concepts becomes apparent. Practical aspects of developing performance/quality indicators will be discussed.

Course Objectives:

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP) based on E6 Revision Version 4, R2 Addendum. Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. Audit and FDA inspection preparation will covered, as well as an inspection handling and response strategies will be reviewed.

Why Should You Attend:

This course is designed to help auditors meet these challenges proactively, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques.

Course Outline:

• Regulatory Trends: Review of Recent FDA Findings for Sponsors, CROs, Monitors, IRBs, and Sites
• Define key GCP elements
• Review recent ICH GCP, E6, R2 Addendum revisions and discuss practical implications
• Explain the differences between the legal and procedural elements of GCP
• Risk-Based Auditing: Applying Risk Assessment and Management Principles to Clinical Quality Assurance
• Develop relevant metrics as quality and key risk indicators (KRIs) for Risk-Based Quality Management (RBQM) systems to proactively identify and mitigate risk
• Risk Based Quality Management (RBQM) Systems: Program Design and Implementation
• Describe the elements of a functional Quality System
• Develop and implement site-specific approaches for corrective action of non-compliance
• Achieving "GCP Inspection Readiness": Preparation, Process, and Ongoing Preparedness 
• GCP Compliance with Standard Operating Procedures (SOPs): Development, Implementation, and Management
• Ensuring Site Compliance and Managing Non-Compliance, including Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) for Sites
• Performing Mock Audits to Identify Strengths and Address Weaknesses
• Preparation, handling and response to FDA inspections.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This course is recommended for:

• Clinical Quality Assurance Professionals,
• Clinical Research Associates,
• Project Managers,
• Investigators,
• Study Coordinators, and
• Regulatory Affairs Professionals.