{"product_id":"decoding-fda-s-draft-guidance-on-remote-regulatory-assessments-a-practical-guide-2026-11-09","title":"Decoding FDA's Draft Guidance on Remote Regulatory Assessments: A Practical Guide","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar provides a comprehensive overview of the FDA's recently released draft guidance on Conducting Remote Regulatory Assessments (RRAs). Learners will gain a thorough understanding of RRAs, their implementation, and their impact on FDA-regulated industries. We will explore the key aspects of the guidance, including the types of RRAs, FDA's expectations, and the potential consequences for regulated entities. By the end of the web seminar, attendees will be equipped with practical knowledge to navigate the evolving landscape of remote regulatory oversight. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine RRAs and differentiate them from traditional inspections\u003c\/li\u003e \u003cli\u003eIdentify the circumstances under which FDA may initiate or request an RRA\u003c\/li\u003e \u003cli\u003eReview the difference between a Mandatory and Voluntary RRA\u003c\/li\u003e \u003cli\u003eDescribe the expectations and technological requirements for participating in an RRA\u003c\/li\u003e \u003cli\u003eExplain the potential consequences of declining to participate in mandatory RRAs\u003c\/li\u003e \u003cli\u003eDevelop effective strategies for preparing and responding to RRA requests\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eQuality Assurance Managers\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eCompliance Officers\u003c\/li\u003e \u003cli\u003eClinical Trial Managers\u003c\/li\u003e \u003cli\u003eClinical Operations Directors\u003c\/li\u003e \u003cli\u003eCRO Project Managers\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eElizabeth Ronk Nelson, M.P.H.\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$835*\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#: 0778-0000-25-021-L99-P. Released: 1\/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 \u003cfont color=\"black\" face=\"Verdana, Arial, Helvetica, sans-serif\" size=\"-1\"\u003e \u003c\/font\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375369183597,"sku":"BI17519","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/decoding-fda-s-draft-guidance-on-remote-regulatory-assessments-a-practical-guide-2026-11-09","provider":"Barnett International ","version":"1.0","type":"link"}