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

• 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

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

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.