Good Clinical Practices (GCP) Compliance Audit Preparation and Inspection Readiness 2018 is a webinar that covers topics such as:
- 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
Good Clinical Practices (GCP) Compliance Audit Preparation and Inspection Readiness 2018 is intended for:
- Compliance Managers
- Clinical Quality Control/Assurance Professionals
- Project Managers
- Clinical Research Associates
- Study Coordinators
- Investigators
- Regulatory Affairs Professionals
