OVERVIEW

10-Week Advanced FDA Post-Marketing Pharmacovigilance Auditing is organized by Barnett International and will be held from Jan 23 - Mar 27, 2026.

Course Description:
This 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.

Participants 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.

Prior 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.

Learning Objectives:

Prepare relevant PV audit plans, audit agendas and preaudit document requests based on the type of PV audit to be performed
Identify the strategy for planning for a specific audit
Identify relevant preaudit document requests based on the audit type
Determine the best audit strategy to conduct an audit based on the PV audit type and participants
Determine whether scoped PV activities meet PVA/SDEA, contractual and regulatory requirements
Identify and develop audit findings based on applicable observation categorizations

Course Outline:

Module 1: Planning for the PV Audit
Module 2: Understanding the FDA Regulations and what they mean to daily PV practice
Module 3: The Quality Management System (QMS) and why it matters to PV
Module 4: Conducting the audit
Module 5: Writing the audit report
Module 6: The PV auditors role in the review of the auditees CAPA plan and CAPA responses