Barnett International/CHI’s Fourth Annual
Clinical Auditing Forum
Ensuring Audit Readiness and GCP Compliance
Across Clinical Research Functions
June 4-5, 2014, Hilton Boston Back Bay, Boston, MA
Barnett International/CHI is pleased to announce a Call for Speaker Proposals for our fourth annual Clinical Auditing Forum, an event focused on risk-based auditing techniques, quality systems-based approaches to auditing and ensuring GCP inspection readiness. Building on the success of previous years’ events, we invite thought leaders to submit their abstracts related to strengthening auditing programs, ensuring compliance, managing non-compliance, RCA and CAPA, and international auditing techniques. We invite abstracts with real-world examples of risk-based approaches to auditing sites, systems, and providers. We seek thought leaders to provide insights, case studies, hands-on activities, and take-away tools for clinical auditors.
We invite presentations on topics such as:
- Assuring Study Quality Using Risk-Based Auditing Techniques
- Quality Systems-Based Approaches to a GCP Auditing Program
- Achieving “GCP Inspection Readiness”: Preparation, Process, and Ongoing Preparedness
- Regulatory Trends: Review of Recent FDA Findings for Sponsors, IRBs, and Sites
- International Audits: Regulatory Requirements, Regional Considerations, and Similarities and Differences from FDA
- Auditing Clinical Research Organizations: Data, Staff Qualifications, Written Procedures, and QA/QC Procedures
- Auditing Other Third Party Vendors: Clinical Laboratories, Site Management Organizations, and Electronic Providers
- 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
- Conducting Internal and Inter-Departmental Audits
- Auditing Sites for Fraud, Bioethics, or Serious Noncompliance
- Auditing IRBs/IECs: Examining IRB/IEC Membership, Qualifications, and Process
- Tools and Apps for Auditors: Making Auditing More Effective and Efficient
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.
The deadline for priority consideration is November 15, 2013.
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 Barnett/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.
To submit a proposal for consideration, please click here.
For more information, please contact:
a division of Cambridge Healthtech Institute
For exhibit and sponsorship information, please contact:
Manager, Business Development
Cambridge Healthtech Institute