New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Pharmacovigilance: Pv audit (English) Course & Certification
Professional
4.4
★★★★★
99% Recommended
3 hours
241 active users
3 points
Your Study Basket
Pharmacovigilance: Pv audit (English)
| Total | |
🎁 FREE Bonus Included
eBookWorth £29— Yours FREE when you purchase today.
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
Pharmacovigilance Audits are a critical part of ensuring that drug safety systems are compliant, effective, and aligned with global regulatory expectations. They evaluate how well pharmacovigilance activities such as case processing, signal detection, reporting, and quality management are performed within an organization.
This Pharmacovigilance Audit Course & Certification provides a practical understanding of pharmacovigilance audit and inspection processes, including regulatory expectations from agencies such as the FDA and MHRA. The course covers audit principles, inspection readiness, audit scope, key system components, checklist development, common findings, and corrective actions. It also explains how to evaluate pharmacovigilance systems and effectively respond to regulatory inspections. Upon completion, learners receive a certification demonstrating their competence in pharmacovigilance auditing and compliance.
Who Should Enrol ?:
- Pharmacovigilance and Drug Safety Professionals
- Quality Assurance and Compliance Auditors
- Regulatory Affairs Professionals
- Clinical Research and Clinical Operations Staff
- Medical Affairs and Pharmacovigilance Managers
- QPPVs and Deputy QPPVs
- Pharmaceutical and Biotechnology Industry Employees
- Internal and External Audit Teams
- Life Science, Pharmacy, and Medical Graduates
- Anyone involved in PV compliance, inspection readiness, or quality systems
What you will learn
Understand the purpose of pharmacovigilance audits and inspections, including regulatory expectations and audit approaches.
Learn how to prepare for pharmacovigilance inspections, assess audit scope, and apply best practices in pharmacovigilance quality processes.
Develop knowledge of pharmacovigilance audit items, reporting procedures, risk assessment, and company information sources used during inspections.
Gain understanding of inspection findings, common regulatory failings, corrective actions, and compliance requirements related to pharmacovigilance systems and processes.
Course Syllabus
- Learning Objectives for this Module
- Audits vs. Inspections
- Why Are Inspections and Audits Needed?
- Who Can Be Audited?
- Approaches
- Achieving Best Practices Through the Pharmacovigilance Audit
- Value Derived
- Scope
- Pharmacovigilance Process Model
- Collection
- Assessment
- Reporting
- Analysis
- Additional Audit Items
- Company Sources of Information to Be Examined
- Pharmacovigilance Checklist
- Risk Profile
- Report Table of Contents
- Limited Diagnostics Can Initiate the Assessment
- Example Inspection – FDA
- MHRA – General Failings
- MHRA – Qualified Person for Pharmacovigilance (QPPV) Failings
- MHRA – Signal Detection Failings
- MHRA – Failure to Update Reference Safety Information
- MHRA – Failure in Processing of ICSRs
- MHRA – Quality Management System Failings
- MHRA – PSUR Failings
- MHRA – Failings in Contracts & Agreements
- MHRA – Other Failings
- How to Address Inspection Findings
- Conclusion
- 📘 Bonus: Pharmacovigilance Audits eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
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)
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
