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. CHI’s fifth annual Clinical Auditing Forum is designed to help auditors meet these challenges head on, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques. We invite thought leaders to submit abstracts with real-world insights and examples of risk-based approaches to auditing sites, systems, and providers.
We invite abstracts on topics that include, but are not limited to:
- Risk-Based Auditing: Applying Risk Assessment and Management Principles to Clinical Quality Assurance
- Regulatory Trends: Review of Recent FDA Findings for Sponsors, CROs, Monitors, IRBs, and Sites
- Quality Management Systems: Program Design and Implementation
- Quality Risk Management (QRM): Developing Metrics and Key Risk Indicators (KRIs) to Proactively Identify and Mitigate Risk
- Auditing Clinical Research Organizations through Qualification, Selection, and Ongoing Oversight
- Auditing Technology Providers, Site Management Organizations, and Other Partners
- Responding to Audit Observations with Your Third Party Vendor
- Achieving “GCP Inspection Readiness”: Preparation, Process, and Ongoing Preparedness
- International Audits: Regulatory Requirements, Regional Considerations, and Similarities and Differences from FDA
- 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
- Auditing Sites for Fraud, Bioethics, or Serious Noncompliance
Industry professionals with best practice case studies and other thought leaders are encouraged to submit a session title, summary of a proposed presentation, and brief biography for consideration. To submit a proposal for consideration, please click here.
The deadline for priority consideration is December 17, 2014.
All proposals are subject to review by the program Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference is given to abstracts from those within pharmaceutical and biotech companies, regulators, and those from academic centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
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