Barnett International/CHI’s fourth annual Clinical Auditing Forum will feature best practices for risk-based auditing techniques, quality systems-based approaches to auditing, and ensuring GCP inspection readiness. This event will focus on how to strengthen auditing programs, ensure compliance, manage non-compliance, RCA and CAPA, and international auditing techniques. Participants will benefit from real-world examples of risk-based approaches to auditing sites, systems, and providers, as well as insights, case studies, hands-on activities, and take-away tools for clinical auditors.
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Wednesday, June 4, 2014
7:00 am Registration and Morning Coffee
8:00 Barnett Welcome & Chairperson’s Opening Remarks
8:15 Change at FDA Brings Challenge to Industry
Jerri B. Perkins, M.D., former Medical Officer, FDA
Currently FDA is challenging the oversight of clinical investigations with a risk-based approach. This session will include an overview by a former FDA medical officer of the importance of how high quality monitoring/auditing can help ensure sites are prepared for FDA inspections. Utilizing case studies and questions from participants, we will de-mystify the process of FDA audits using this new Guidance to Industry. Upon completion of this program participants will be able to:
- Ensure investigational study sites are prepared to meet new guidance
- Understand how key aspects of how the guidance may affect your study plans
- Understand FDA’s latest approach to risk-based clinical investigations
- Know what steps you can take to become a futurist thinker on FDA
9:00 SOP Assessment: Ensuring GCP Compliance in Standard Operating Procedures (SOPs)
Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management
Standard Operating Procedures (SOPs) are defined as detailed, written instructions that permit processes to be executed uniformly. In an effort to ensure compliance with regulations and guidelines, many sponsors, CROs,and clinical research sites have developed and incorporated SOPs into their operations. Although training of staff and assessment of comprehension and compliance are crucial to implementation, the content and structure of SOPs should be routinely audited to take full advantage of their purpose. The session will introduce regulatory expectations for SOPs and some approaches to evaluating SOPs to ensure they are current and compliant. Session objectives include:
- Discuss the FDA’s expectations for Sponsor/CRO, IRB, and Clinical Investigator SOPs
- Examine the systems for compliant development, implementation, and management
9:45 Coffee Break and Exhibit Viewing
10:15 Risk-Based Approach to Internal Audit Schedule
Ellen Liedel-Sargent, Director Clinical Quality Assurance, ICON , Plc.
Implementing an internal audit schedule can help appropriately assess the risks and utilize resources in the most cost effective manner. Annual audit schedules should address site audits, process audits, project- or program-specific audits, and vendor audits. The audit plan should be based on timely identification of risks or issues that allow mitigation in order to preserve the quality of the data and safeguard the study participants. A systematic process can be accomplished using the EMA approach of risk-based quality management in clinical trials. Specifically:
- Identification of risks or areas of risk, and understanding their impact
- Decision making on identification of areas of high risk that may require mitigation or confirmation that potential risks are properly addressed
- Ongoing effectiveness checks to ensure mitigation is providing desired outcome
11:00 Interactive Roundtable Discussions
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 pm Utilization of a Risk-Based Compliance Audit Tool for the Conduct of Audits
Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.
The Compliance Audit Tool will assist auditors in conducting audits and ensuring consistency in capturing and reporting audit findings from compliance audits, such as those performed on clinical trial centers. This risk-based auditing tool contains built in risk assessment methodologies which allows audit findings to be classified by risk impact (high, medium and low).In addition to the classification of audit findings, the use of such a tool will allow trending of audit findings across many types of audits. The compliance audit tool has the ability for automated generation of the audit reports and action plan documents which will allow for a much quicker turnaround time for reporting and CAPA management.
1:45 Building Quality by Design (QbD) and Quality Risk Management (QRM) Systems into Clinical Site Operations: An Academic Clinical Research Site Perspective
Marina Malikova, Ph.D., CCRA, MA, Clinical Investigation, Executive Director, Surgical Translational Research Operations and Compliance, Boston University
At Boston University, we have established Quality by Design (QbD) parameters and Quality Risk Management (QRM). QbD and QRM are a new expectation by regulatory agencies under GCP. In light of RBM and the expansion of QRM, the need for the integration of these two concepts becomes apparent. The premise behind RBM is that monitoring quality can improve by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site level. QRM is the proactive identification and mitigation of risks. By combining these two concepts, the inherent risks identified up front can feed into the design of the RBM plan QbD. This session will demonstrate practical aspects of developing key performance and quality indicators at all stages, and follow-up of the identified signals.
2:30 Regulatory Trends: Review of Recent FDA 483/Warning Letters Findings for Sponsors, IRBs, and Sites
Paul Papagni, Executive Director, Research, Holy Cross Hospital CHE
FDA findings serve as an excellent training and audit preparedness tool to ensure that you are focusing on relevant risks. Research teams, sponsors, and IRBs can learn from the past mistakes of others and utilize findings as a checklist for future self-audits and training. “We are in this together” the FDA is helping to align and delineate priorities to ensure safe, high quality clinical trials. Is your “risk-based” plan adequate to address unanticipated problems? After this session, participants will be able to:
- Develop a checklist for compliance based on FDA findings
- Identify current “hot topics” and trends in research compliance
- Develop training programs to anticipate FDA Visits and ensure “audit readiness”
3:15 Sponsored Presentation (Opportunity Available)
3:30 Refreshment Break and Exhibit Viewing
3:50 International Audits: Regulatory Requirements, Regional Considerations and Similarities and Differences from FDA
Speaker to be Announced
4:35 Comparing Drug to Device GCPs: ISO 14155 to ICH E6
Lee Truax-Bellows, President, CEO, Clinical, NCRA
Back in 1996 the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) adopted the ICH E6 guideline in regards Good Clinical Practice (GCP) for drug studies and more recently (2012) FDA’s Center for Devices and Radiological Health (CDRH) recognized the ISO 14155 Standard for GCP conduct within medical device studies. Though there are many similarities between the two, each also has unique characteristics, right down to why FDA can adopt one but only recognize the second. This presentation will outline the purpose of the ICH E6 guideline and the ISO 1455 Standard. Differences and similarities between the two approaches will be discussed.
5:20 Welcome Reception and Exhibit Viewing (Sponsorship Opportunity Available)
6:20 Close of Day One
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