Ms. Sheri Kuss has over 20 years of clinical research experience in the industry working at pharmaceutical, medical device, CRO and biotechnology companies. Sheri's vast range of expertise has developed from her roles within clinical trial monitoring, clinical trial management and operations, clinical quality assurance and compliance, training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools and programs as a direct result of her experiences hosting and preparing for more than 15 pre-approval regulatory agency inspections. Following the companys receipt of an FDA Warning Letter for monitoring and investigator misconduct-related findings, Sheri served as a subject matter expert on a select committee that performed a gap analysis and implemented global remediation plans. In the area of operational excellence, she demonstrated success in leading business process teams and improving upon existing quality management systems through continuous improvement initiatives. Sheri's Sponsor and CRO experiences give her a unique quality insight and a practical approach to the risks and operational compliance issues related to quality management systems and the conduct of clinical trials.