{"product_id":"16-hour-preparing-for-fda-post-marketing-adverse-drug-experience-pade-inspections-for-pharmacovigilance-2026-08-28","title":"16-Hour Preparing for FDA Post Marketing Adverse Drug Experience (PADE) Inspections for Pharmacovigilance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cdiv\u003e \u003cp\u003eThe FDA PADE inspection is an integral part of the FDA safety surveillance program for FDA-regulated drug and therapeutic biologic products. The PADE inspection is administered under the FDA Compliance Program, specifically, as part of program 7353.001: CHAPTER 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products. \u003c\/p\u003e \u003cp\u003eThis course will provide attendees with a general understanding the PADE inspection, the impact on pharmacovigilance and the overall organization and how to effectively prepare for, participate in and respond to the PADE inspection from a pharmacovigilance perspective.\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\u003eUnderstand the PADE inspection in relation to the organization's product approval\u003c\/li\u003e \u003cli\u003eExplain what being inspection ready means\u003c\/li\u003e \u003cli\u003eUnderstand how to effectively prepare your pharmacovigilance team for the PADE inspection\u003c\/li\u003e \u003cli\u003eIdentify how to effectively plan for a PADE inspection\u003c\/li\u003e \u003cli\u003ePlanning for gaps that may come up during a PADE inspection\u003c\/li\u003e \u003cli\u003eUnderstand how to interface with the PADE inspector\u003c\/li\u003e \u003cli\u003eDetermine how to respond to PADE inspection findings \u003c\/li\u003e \u003cli\u003eUnderstand how to continue effective inspection readiness following the PADE inspection\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: The PADE Inspection explained and understanding why they are performed\u003c\/li\u003e \u003cli\u003eModule 2: The scope of the PADE inspection in relation to your company\u003c\/li\u003e \u003cli\u003eModule 3: Preparing for the PADE inspection\u003c\/li\u003e \u003cli\u003eModule 4: Participating in the PADE inspection\u003c\/li\u003e \u003cli\u003eModule 5: Responding to pharmacovigilance observations identified during the PADE inspection\u003c\/li\u003e \u003cli\u003eModule 6: Maintaining inspection readiness following the PADE inspection\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eBusiness Development Personnel\u003c\/li\u003e \u003cli\u003eCommercial Personnel\u003c\/li\u003e \u003cli\u003eHeads of Pharmacovigilance Departments\u003c\/li\u003e \u003cli\u003eHeads of Pharmacovigilance Operations\u003c\/li\u003e \u003cli\u003eMarketing Personnel\u003c\/li\u003e \u003cli\u003eMedical Affairs Personnel\u003c\/li\u003e \u003cli\u003eOther Personnel that would participate in the PADE inspection\u003c\/li\u003e \u003cli\u003eQuality Assurance personnel \u003c\/li\u003e \u003cli\u003eRegulatory Personnel\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\u003e4 weeks for 4 hours each week.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e \u003cp\u003e$1,795 by Early Bird Deadline \u003c\/p\u003e \u003cp\u003e$1,995 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 16 hours (1.6 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#: 0778-0000-25-059-L99-P. Released: 9\/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":53375391301997,"sku":"BI17316","price":2195.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375391334765,"sku":"BI17316-ACADEMIC","price":1995.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/16-hour-preparing-for-fda-post-marketing-adverse-drug-experience-pade-inspections-for-pharmacovigilance-2026-08-28","provider":"Barnett International ","version":"1.0","type":"link"}