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

Date Dec 11, 2018
Time (1:00 pm to 2:00 pm)
Cost $200.00
Online
This Good clinical research practices and auditing (GCP) webinar will teach how to get rid of challenges related to clinical practice in particular to data quality and regulatory risk proactively, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques.

Risk-based principles and quality management systems are the new reality of clinical auditing. Building on 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.

This webinar will provide an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). 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.

Areas Covered in the Session :
  • Define key GCP elements
  • Identify the universal components of GCP
  • Explain the differences between the legal and procedural elements of GCP
  • Recognize key differences in GCP for drug, device, and biologics
  • Describe the overlap between GCP, GLP and GMP
  • Risk-Based Auditing: Applying risk assessment and management principles to clinical quality assurance
  • Describe the key principles of Six Sigma for process improvement and Quality by Design (QbD)
  • Develop relevant metrics as quality and key risk indicators (KRIs) for Risk-Based Quality Management (RBQM) systems to proactively identify and mitigate risk
  • Quality Management 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
  • Examine recent trends in non-compliance
  • Regulatory Trends: Review of recent FDA findings for Sponsors, CROs, Monitors, IRBs, and Sites
  • Auditing Clinical Research Organizations (CROs) through Qualification, Selection, and Ongoing Oversight
  • Auditing Technology Providers, Site Management Organizations (SMOs), and Other Partners
  • Responding to Audit Observations with your third party vendor
  • 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 noncompliance, including Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) for sites
  • Performing mock audits to identify strengths and address weaknesses
  • Auditing sites for fraud, bioethics, or serious noncompliance
Who Should Attend:
  • Clinical Quality Control/Assurance Professionals
  • Compliance Managers
  • Clinical Research Associates
  • Project Managers
  • Investigators
  • Study Coordinators
  • Regulatory Affairs Professionals

 


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