Since the introduction of the new pharmacovigilance legislation in the EU, QMS and self-audits have become an increasingly important topics. 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, real life 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
Speakers
Mr Graeme Ladds,
Director ,
PharSafer Associates Ltd.Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
Who Should Attend
QA representatives, EU QPPVs and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.
