Pharmacovigilance QMS & Inspection Preparation
Since the introduction of the new pharmacovigilance legislation in the EU, QMS and self-audits have become an increasingly important topic. Companies have been challenged by regulators to implement risk-based audits where continual improvement of processes, systems and compliance to regulations needs to be demonstrated. This is required from the top of the company organisation in all areas of regulatory activity including clinical, pharmacovigilance, sales and marketing, IT and medical services.
This must-attend course will explain principles, approaches and regulatory expectations for the pharmacovigilance QMS and risk-based audits and has been designed to help in both the assessments of risk and the whole CAPA process. The highly participative programme will include a mix of presentations from our expert trainer, reallife case studies and practical workshop sessions which will help consolidate learning.
Benefits of attending:
- Explore pharmacovigilance quality management systems (QMS) and risk-based audits
- Learn the importance of key performance indicators (KPIs) in your QMS
- Ensure compliance with assessments of risk and your CAPA plans
- Discuss pharmacovigilance inspections and QMS activities
Upcoming start dates
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Reviews by course attendees
Average rating 4.8
The speaker was very knowledgeable and easy to approach and I would definitely attend another course that had him as trainer. The practical examples were very useful and the cou...
Excellent presentation by a very experienced speaker. The examples provided and the exercises were greatly appreciated.
The speaker was very very good and I particularly liked the opportunity to exchange experiences and examples.