Good Pharmacovigilance Practice Training
About This Course
Our face-to-face course, complete with presentations, group discussions and case examples, promises to make pharmacovigilance colorful, dynamic, marvelous and interesting.
The aim of this interactive one-day course is to provide an introduction to Good Pharmacovigilance Practice (GVP) for those at the Good Manufacturing Practice (GMP)/GVP interface. This includes those managing product quality complaints, supply/distribution chains and GMP quality systems. We also explore the contrasting role of the Qualified Person (QP) for pharmacovigilance.
Key Learning Objectives
By the end of this course, you will:
- Be able to outline the key principles of GVP and have an overview of key European GVP legislation and guidance
- Understand the links between the pharmacovigilance and GMP systems in a company
- Have evaluated a typical pharmacovigilance system and be able to describe at least three aspects where GMP and GVP systems have critical interfaces
- Have an awareness of, and have received information on, hot topics including electronic records, data integrity and the role of the QP for pharmacovigilance
- Have discussed and received information on common GVP inspection findings
Who Should Attend
- Affiliate/country organizations’ quality assurance (QA) and pharmacovigilance staff
- GMP auditors, QPs and technical specialists (responsible for the management of product quality complaints and/or distributors)
- GVP and GMP managers wishing to gain an understanding of this Good Practice (GxP) interface and current regulatory hot topics
Discounts offered to NHS staff, regulators and charities.
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