In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

This audio conference covers:

• How noncompliance and trial data mishaps confound study results
• Clinical study audit planning
• Auditor selection and qualifications
• Executing the audit plan and agenda preparation
• Conducting investigator site audits – tips and tools
• Conducting CRO audits – systems to ensure effective management of your trial
• Sponsor inspection readiness
• Corrective and preventative action strategies
• Inspection trends and initiatives

About the speaker:

Carol Houts is the Director of Regulatory, Quality and Safety at Pleiad Inc, a full service medical device CRO. She has more than 14 years of experience in quality, regulatory affairs, compliance, auditing, data management systems, vigilance, post market surveillance, supplier management and regulatory compliance in both the medical device and pharmaceutical industries. Her regulatory expertise encompasses North America and European regulatory requirements, and she has supported both pilot and pivotal drug and device trials.

Who should attend?

• Regulatory specialists and managers
• Clinical managers
• Clinical research coordinators
• Clinical project managers
• Clinical research associates
• Quality assurance managers and associates
• Auditors

This audio conference is rated General Interest.