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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 from clinical, pharmacovigilance, sales and marketing, IT and medical services.
This course is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.
Benefits of attending:
Understand 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 and preventative actions
Discuss pharmacovigilance inspections and QMS activities
