{"product_id":"building-quality-by-design-qbd-and-risk-based-quality-management-rbqm-systems-into-clinical-operations-2026-12-09","title":"Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe premise behind RBQM is that monitoring quality can be improved by leveraging existing data. The development of quality and risk management metrics involves identifying the values of an organization, and this web seminar will focus on developing measures to assess meeting those goals, building infrastructure to capture data to support the metrics, and establishing adequate and timely responses to drive improvement. As the industry's utilization of risk-based monitoring continues to increase along with the development and expansion of RBQM, the need for integrating these two concepts is necessary.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the principles of QbD and new regulatory requirements for risk-based monitoring\u003c\/li\u003e \u003cli\u003eProvide an overview of GCP regulations and recent ICH GCP E6 and E8 revisions and their impact on QC\/QA process and RBQM systems\u003c\/li\u003e \u003cli\u003eDevelop relevant metrics as quality and performance indicators for RBQM systems and effective Corrective and Preventive Action (CAPA) Plans\u003c\/li\u003e \u003cli\u003eReview recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs\u003c\/li\u003e \u003cli\u003eIdentify and manage risks of clinical trials\u003c\/li\u003e \u003cli\u003ePerform cause-effect analysis for risks and develop mitigation strategies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Quality Assurance Auditors\u003c\/li\u003e \u003cli\u003eClinical Quality and Compliance Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers and Medical Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Principal Investigators and Research Coordinators\u003c\/li\u003e \u003cli\u003eIRB Administrators and Members\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eMarina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/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\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\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 1.5 hours (0.15 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#: 0778-0000-24-043-L99-P. Released: 9\/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":53375366594925,"sku":"BI17581","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/building-quality-by-design-qbd-and-risk-based-quality-management-rbqm-systems-into-clinical-operations-2026-12-09","provider":"Barnett International ","version":"1.0","type":"link"}