Pharmacovigilance QMS & Inspection Preparation
Since the introduction of the new pharmacovigilance legislation in the EU, Quality Management Systems (QMS)
and self-audits have become a hot and growing topic. Companies have been increasingly challenged by regulators to implement risk-based audits where con- tinual 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, regulatory; pharmacoviglance, sales & 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.
Who should attend?
QA representatives, EU QPPV and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.