Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses

Pharmacovigilance 3 - Pv Audit

Module 3 of 4 - Pharmacovigilance Audit Course

If you need to ensure that your company is prepared for an inspection by a regulatory body, then The Pharmacovigilance Audit course will help you comply with the principles and guidelines they have set within their legislative requirements. This course will help you conduct a diagnostic overview of pharmacovigilance activities to gain a rapid understanding of the company’s current position, against the best means of practice that correspond with regulations. The course contains interactive mini exams at the end of each chapter to help reinforce learning. Updated December 2021.

  • Average study time:
    study time

    3 hrs

  • Personal development points (CPD):

    3 points

  • Price:


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Course Details

The Pharmacovigilance Audit course is perfect for you if are involved in all areas of drug safety, pharmacovigilance, regulatory and quality compliance. The course covers the key components of audits and inspections; including why they are conducted, different types of approaches to audits and how to prepare for inspections.

This course delivers an introduction to the basics of pharmacovigilance & drug safety, including in-depth explanations of audits & inspections, as well as an explanation of how to prepare for a pharmacovigilance inspection. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge of pharmacovigilance auditing.

Benefits for you

  • CPD Points - Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
  • Certification - Receive a personal certificate to show your subject knowledge on course completion.
  • Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
  • Flexibility - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
  • Keep Up to Date - You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.
  • Learn from Industry Experts - The course content has been developed to ensure that you comply with pharmacovigilance legislation through the application of learning outcomes. The course is written by Steve Jolley, who is a chairperson for the Drug Information Association (DIA)

Course Syllabus

1. Learning Objectives

  • 1.1 Learning Objectives for this Module 

2. Audits & Inspections 

  • 2.1 Audits vs Inspections 
  • 2.2 Why are inspections and audits needed? 
  • 2.3 Types of Audits & Inspections 
  • 2.4 Who Can be Audited? 
  • 2.5 Approaches
  • 2.6 Mini exam 

3. Preparing for a Pharmacovigilance Inspection 

  • 3.1 Achieving Best Practices through the Pharmacovigilance Audit 
  • 3.2 Value Derived 
  • 3.3 Scope 
  • 3.4 Pharmacovigilance Process Model 
  • 3.5 Mini exam

4. Audit Items 

  • 4.1 Collection 
  • 4.2 Assessment 
  • 4.3 Reporting 
  • 4.4 Analysis 
  • 4.5 Additional Audit Items
  • 4.6 Mini exam 

5. Company Sources of Information to be Examined 

  • 5.1 Company Sources of Information to be Examined
  • 5.2 Mini exam 

6. Pharmacovigilance Checklist 

  • 6.1 Pharmacovigilance Checklist 
  • 6.2 Risk Profile 
  • 6.3 Report Table of Contents 
  • 6.4 Limited Diagnostic Can Initiate the Assessment 
  • 6.5 Mini exam

7. Inspection Findings & Suitable Actions 

  • 7.1 Example Inspection - FDA 
  • 7.2 MHRA - General Failings 
  • 7.3 MHRA - Qualified Person for Pharmacovigilance (QPPV) Failings 
  • 7.4 MHRA - Signal detection Failings 
  • 7.5 MHRA - Failure to Update Reference Safety Information 
  • 7.6 MHRA - Failure in Processing of ICSRs 
  • 7.7 MHRA - Quality Management System Failings 
  • 7.8 MHRA - PSUR Failings 
  • 7.9 MHRA - Failings in Contracts & Agreements 
  • 7.10 MHRA - Other Failings 
  • 7.11 How to Address Inspection Findings 
  • 7.12 Conclusion
  • 7.13 Mini exam


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