{"product_id":"10-week-risk-management-risk-based-quality-management-for-clinical-trials-certification-program-2026-08-07","title":"10-Week Risk Management\/Risk-Based Quality Management for Clinical Trials Certification Program","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cdiv\u003e \u003cp\u003eAre you prepared for Quality Risk Management (QRM), Risk Management (RM), Risk-Based Quality Management (RBQM)? The finalization of ICH GCP E6(R3) in January 2025 revealed that the guideline still requires risk-based approaches to managing quality in clinical trials. This 10-Week series takes you through, step-by-step, how to execute these requirements. We will focus on the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6(R3) expectations, while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Each step of risk identification, assessment, control, review, reporting, management, and communication are also reviewed along with what is to be documented in the clinical study report.\u003c\/p\u003e \u003cp\u003ePrior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the expectations of QRM in relation to the ICH E6(R3) updates\u003c\/li\u003e \u003cli\u003eDiscuss how to analyze risks and develop a risk register\u003c\/li\u003e \u003cli\u003eDescribe how to use multiple risk analysis tools including: Failure Mode Effect Analysis (FMEA), Bow Tie, and Affinity Diagram\u003c\/li\u003e \u003cli\u003eDescribe how to formulate risk mitigation strategies\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Quality Risk Management: Quality Risk Management\/Risk Management (ICH GCP E6(R3) and ISO 31000), Risk Management Policy\/ Program, Accountability and Resources\u003c\/li\u003e \u003cli\u003eModule 2: Risk Management Plan and Culture: Framework for Communicating Risk Within an Organization\/Program, Strategies and Challenges for Risk Stakeholders, Required Commitment and Mandate\u003c\/li\u003e \u003cli\u003eModule 3: Risk Identification: Risk Identification and When to Start, Protocol Risks, Risk Register (Risk Log) for Tracking Risks\u003c\/li\u003e \u003cli\u003eModule 4: Risk Evaluation: Impact of Error, Detection of the Error, Risk Priority Number (RPN) Values\u003c\/li\u003e \u003cli\u003eModule 5: Risk Analysis Tools Part I: FMEA, Bow Tie, and Delphi technique\u003c\/li\u003e \u003cli\u003eModule 6: Risk Analysis Tools Part II: SWOT (Strengths, Weakness, Opportunities, Threats), Affinity Diagram, Cause and Effect Analysis\u003c\/li\u003e \u003cli\u003eModule 7: Risk Control: Risk Mitigation Strategies, Risk Mitigation Options, Priority Rankings of Risk Mitigation Plans\u003c\/li\u003e \u003cli\u003eModule 8: Risk Communication: Risk Mitigation Plans in the Risk Register\/Log, Impact of Internal and External Stakeholders, Escalation Processes and Plans\u003c\/li\u003e \u003cli\u003eModule 9: Risk Review: Periodic Review, Risk Assessment, and Risk Detection\u003c\/li\u003e \u003cli\u003eModule 10: Risk Reporting: Risks, Deviations, Predefined Quality Tolerance Limits, Lessons Learned\/Continuous Learning, Required Documentation in the Clinical Study Report\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eQuality Control\/Assurance Professionals\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Research\/Operations Personnel\u003c\/li\u003e \u003cli\u003eInformation Technology\/Security Personnel\u003c\/li\u003e \u003cli\u003eData Managers\u003c\/li\u003e \u003cli\u003eStudy Managers\u003c\/li\u003e \u003cli\u003eProject Physicians\/Medical Monitors\u003c\/li\u003e \u003cli\u003ePharmacovigilance Professionals\u003c\/li\u003e \u003cli\u003eBiostatisticians\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e \u003cp class=\"abstract\"\u003e\u003cspan class=\"bold\"\u003eWhat previous students have said ...\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\"This course is beyond my expectation with very practical examples and tools. Both instructors are excellent with great attention to address participants' questions.\"\u003c\/p\u003e \u003cp\u003e\"The course was well designed. These lessons were valuable in seeing the big picture of clinical research.\"\u003c\/p\u003e \u003cp\u003e\"The tools provided were great. I hope to use the risk log and risk analysis tools.\"\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e \u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e \u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e \u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.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\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e\u003c\/b\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e10 weeks for 2 hours each week.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e \u003cp\u003e$1,695 by Early Bird Deadline \u003c\/p\u003e \u003cp\u003e$1,895 after Early Bird Deadline\u003c\/p\u003e \u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e \u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\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 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-23-005-L99-P. Released: 4\/23.\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\u003c\/p\u003e \u003c\/div\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375363580269,"sku":"BI17665","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375363613037,"sku":"BI17665-ACADEMIC","price":1695.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/10-week-risk-management-risk-based-quality-management-for-clinical-trials-certification-program-2026-08-07","provider":"Barnett International ","version":"1.0","type":"link"}