{"product_id":"root-cause-analysis-rca-and-corrective-and-preventive-action-capa-in-site-management-2026-10-14","title":"Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eManaging investigator noncompliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify noncompliance, correct the noncompliance through intervention, and evaluate the effectiveness of the intervention. Root cause analysis provides a process through which issues can be accurately identified and interventions can be effectively designed. The corrective action process including, when appropriate, preventive action planning, should be implemented when RCA has been completed. An effective CAPA process can lead to improved human subject protections and confidence in the integrity of the data. Lack of effective corrective action management can lead to repeated noncompliance, compromised subject safety, poor data quality, and\/ or unacceptable inspection findings with subsequent negative impact on the final submission. This course focuses specifically on the management of noncompliance issues occurring at investigative sites.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine investigator and site noncompliance\u003c\/li\u003e \u003cli\u003eDescribe performance management concepts and skills for effective site risk management\u003c\/li\u003e \u003cli\u003eIntegrate prevention of performance issues and ensure adequate site issues management\u003c\/li\u003e \u003cli\u003eImplement Gilbert's Behavioral Engineering Model for a diagnostic root cause analysis process\u003c\/li\u003e \u003cli\u003eApply performance management concepts in case studies with a focus on prevention and issues management\u003c\/li\u003e \u003cli\u003eRecognize components of effective corrective action planning and documentation\u003c\/li\u003e \u003cli\u003eIdentify examples of corrective action planning for different site noncompliance case scenarios\u003c\/li\u003e \u003cli\u003eDiscuss successful preventive action planning and implementation\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Associates, Project Managers and Clinical Research Associate Managers\u003c\/li\u003e \u003cli\u003ePrincipal Investigators, Site Research Directors and Coordinators\u003c\/li\u003e \u003cli\u003eQuality Assurance Staff\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eJanet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.\u003c\/p\u003e\u003cp\u003eLily Romero, P.A., C.C.R.C.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eDefining Investigator Noncompliance:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRegulatory definitions and categories\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003ePerformance Management Concepts:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eTheories of motivation, taking a risk-based approach to monitoring, issues escalation and management\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eRoot Cause Analysis:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDetailed examination of Gilbert's Behavioral Engineering Model and its application to root cause analysis\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eApplication of Root Cause Analysis Concepts:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eBehavioral interviewing, the 5 Why's, and open-ended questions\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay Two\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eApplication of Performance Management Concepts:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e7 Comprehensive compliance management steps\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eCorrective and Preventive Action Plans (CAPA) - Concepts and Examples:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eProblem solving and implementing both short-term corrective and long-term preventive actions\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eDocumenting Investigator Noncompliance:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eLinking noncompliance to regulatory requirements; documentation best practices\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eExercises in Concept Application:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eReview and critique of simulated monitoring reports documenting noncompliance and CAPA\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIndividual case studies (based on actual FDA warning letters) are assigned to each participant to practice and apply\u003c\/li\u003e \u003cli\u003eIdentification of noncompliance and Questions to ask to determine the root cause\u003c\/li\u003e \u003cli\u003eIdentification of necessary corrective and preventive actions\u003c\/li\u003e \u003cli\u003eIdentification of necessary preventive actions\u003c\/li\u003e \u003cli\u003eDocumenting the issue in monitoring reports and correspondence\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cdiv\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/div\u003e\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\u003cdiv\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e \u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e \u003c\/div\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-24-057-L99-P. Released: 10\/24. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375359287661,"sku":"SRCJ1026","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375359320429,"sku":"SRCJ1026-ACADEMIC","price":1475.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/root-cause-analysis-rca-and-corrective-and-preventive-action-capa-in-site-management-2026-10-14","provider":"Barnett International ","version":"1.0","type":"link"}