Good Clinical Practices (GCP) Compliance – Audit Preparation and Inspection Readiness 2018

Topics

• Identify the universal components of GCP
• Define key GCP elements
• Recognize key differences in GCP for drug, device, and biologics
• Explain the differences between the legal and procedural elements of GCP
• Risk-Based Auditing: Applying risk assessment and management principles to clinical quality assurance
• Describe the overlap between GCP, GLP and GMP
• Develop relevant metrics as quality and key risk indicators (KRIs) for Risk-Based Quality Management (RBQM) systems to proactively identify and mitigate risk
• Describe the key principles of Six Sigma for process improvement and Quality by Design (QbD)
• Describe the elements of a functional quality system
• Quality Management Systems: Program design and implementation
• Examine recent trends in non-compliance
• Develop and implement site-specific approaches for corrective action of non-compliance
• Auditing Clinical Research Organizations (CROs) through Qualification, Selection, and Ongoing Oversight
• Regulatory Trends: Review of recent FDA findings for Sponsors, CROs, Monitors, IRBs, and Sites
• Responding to Audit Observations with your third party vendor
• Auditing Technology Providers, Site Management Organizations (SMOs), and Other Partners
• GCP Compliance with Standard Operating Procedures (SOPs): Development, Implementation, and Management
• Achieving "GCP Inspection Readiness": Preparation, Process, and Ongoing Preparedness
• Performing mock audits to identify strengths and address weaknesses
• Ensuring site compliance and managing noncompliance, including Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) for sites
• Auditing sites for fraud, bioethics, or serious noncompliance

Who should Attend

• Compliance Managers
• Clinical Quality Control/Assurance Professionals
• Project Managers
• Clinical Research Associates
• Study Coordinators
• Investigators
• Regulatory Affairs Professionals