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.
Upcoming start dates
Suitability - Who should attend?
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
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Reviews by course attendees
Average rating 4.8
Graeme is very skilled professional, who was able to transfer example from real life experience and deliverables in a straightforward and effective way.
[The presenter] has huge knowledge and gave real-life examples... the best thing was the practical exercise it will be a great guide to us.
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Excellent, his experience and extensive knowledge are evident. It's been a pleasure to learn from him. I really liked the presentation and the speaker. Clear ideas, all the topi...