10-Week Advanced Postmarketing Pharmacovigilance Auditing for the USA

Jun 24, 2025, 15:50 PM
Course ID : 325
Acronym : PHVA
325

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

Who Should Attend

  • Heads of Pharmacovigilance Departments
  • Heads of Pharmacovigilance Quality Assurance Departments
  • Heads of PV Operations
  • Pharmacovigilance Auditors
  • Quality Assurance Staff responsible for pharmacovigilance self-inspections
  • Relevant Pharmacovigilance Staff

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“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.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“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!”

Instructor

Heather Murphy, R.N., M.B.A., CQA

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,995 by Early Bird Deadline

$2,195 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett 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. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

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