{"product_id":"10-week-advanced-fda-post-marketing-pharmacovigilance-auditing-2026-12-11","title":"10-Week Advanced FDA Post-Marketing Pharmacovigilance Auditing","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cdiv\u003e \u003cp\u003eThis advanced pharmacovigilance (PV) course targets professionals with 10+ years of PV experience and at least 5 years of auditing experience who seek to enhance their auditing expertise. The curriculum covers FDA postmarketing surveillance regulations under Chapter 53, including CFR Parts 208.198, 314.80, and Part 11, focusing on adverse event data management and regulatory compliance expectations. \u003c\/p\u003e \u003cp\u003eParticipants will learn comprehensive audit methodologies for various USA-specific PV scenarios, including specialty pharmacy, market research, REMS, business partnerships, medical information centers, CROs, and distribution facilities. The course emphasizes practical skills in audit planning, execution, report development, observation identification, and CAPA review processes, with particular focus on preparing organizations for FDA inspections while covering critical areas such as literature evaluation, signal detection, aggregate reporting, and pharmacovigilance agreements.\u003c\/p\u003e \u003cp\u003e\u003cfont color=\"inherit\" face=\"inherit\" size=\"-1\"\u003e\u003c\/font\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. \u003cfont color=\"inherit\" face=\"inherit\" size=\"-1\"\u003e\u003c\/font\u003e\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003ePrepare relevant PV audit plans, audit agendas and preaudit document requests based on the type of PV audit to be performed \u003c\/li\u003e \u003cli\u003eIdentify the strategy for planning for a specific audit\u003c\/li\u003e \u003cli\u003eIdentify relevant preaudit document requests based on the audit type\u003c\/li\u003e \u003cli\u003eDetermine the best audit strategy to conduct an audit based on the PV audit type and participants\u003c\/li\u003e \u003cli\u003eDetermine whether scoped PV activities meet PVA\/SDEA, contractual and regulatory requirements\u003c\/li\u003e \u003cli\u003eIdentify and develop audit findings based on applicable observation categorizations \u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Planning for the PV Audit\u003c\/li\u003e \u003cli\u003eModule 2: Understanding the FDA Regulations and what they mean to daily PV practice\u003c\/li\u003e \u003cli\u003eModule 3: The Quality Management System (QMS) and why it matters to PV\u003c\/li\u003e \u003cli\u003eModule 4: Conducting the audit\u003c\/li\u003e \u003cli\u003eModule 5: Writing the audit report\u003c\/li\u003e \u003cli\u003eModule 6: The PV auditors role in the review of the auditees CAPA plan and CAPA responses\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eHeads of Pharmacovigilance Departments \u003c\/li\u003e \u003cli\u003eHeads of Pharmacovigilance Quality Assurance Departments \u003c\/li\u003e \u003cli\u003eHeads of PV Operations\u003c\/li\u003e \u003cli\u003ePharmacovigilance Auditors \u003c\/li\u003e \u003cli\u003eQuality Assurance Staff responsible for pharmacovigilance self-inspections \u003c\/li\u003e \u003cli\u003eRelevant Pharmacovigilance Staff\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 participants say about Barnett's 10-Week courses ...\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\"Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.\"\u003c\/p\u003e \u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e \u003cp\u003e\"This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!\"\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e \u003cp\u003eHeather Murphy, R.N., M.B.A., CQA\u003c\/p\u003e \u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-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 3 hours each week.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e \u003cp\u003e$1,995 by Early Bird Deadline \u003c\/p\u003e \u003cp\u003e$2,195 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 30 hours (3.0 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#: 0778-0000-25-057-L99-P. Released: 10\/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\u003c\/p\u003e \u003c\/div\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375371444589,"sku":"BI17462","price":2195.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375371477357,"sku":"BI17462-ACADEMIC","price":1995.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/10-week-advanced-fda-post-marketing-pharmacovigilance-auditing-2026-12-11","provider":"Barnett International ","version":"1.0","type":"link"}