{"product_id":"preparation-management-and-response-to-inspections-and-audits-2026-11-19","title":"Preparation, Management, and Response to Inspections and Audits","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eFaced with an impending audit or inspection, how do you prepare? If inspection results in findings, do you have the skills and tools to best respond to these issues to avoid further actions? This web seminar will provide an overview of what to expect and how to prepare for an audit or inspection. Real case scenarios in a workshop format will be used to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. Steps for preparation, on-site auditing and follow-up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs). \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the anatomy of a regulatory inspection\u003c\/li\u003e \u003cli\u003eRecognize how to best prepare and manage expectations\u003c\/li\u003e \u003cli\u003eDiscuss appropriate strategies for responding to inspection findings and implementing realistic and appropriate corrective and preventive actions (CAPA)\u003c\/li\u003e \u003cli\u003eEmploy the right corrective actions to resolve the major and critical inspection findings\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eRoot Cause Analysis exercise\u003c\/li\u003e \u003cli\u003eForensic examination of FDA Warning Letters\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eInvestigators\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eCompliance Professionals\u003c\/li\u003e \u003cli\u003eProject Managers and Site Managers\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\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\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\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,045*\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 4 hours (0.4 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#: 0778-0000-25-013-L99-P. Released: 3\/25. \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\u003cbr\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375368167789,"sku":"BI17544","price":1045.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/preparation-management-and-response-to-inspections-and-audits-2026-11-19","provider":"Barnett International ","version":"1.0","type":"link"}