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:
QA representatives, EU QPPV and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.
The audit basics
The legislation and audits
QMS and the audit report
You will be asked to design the QMS for a safety department that has recently been audited. You will need to devise a plan based on any risk elements and audit findings identified and look at designing a QMS approach with KPIs.
Introduction to PV inspections
The pharmacovigilance inspection cycle
You will be presented with a series of findings from a regulatory inspection. You will have to look
at the findings and work out priorities, devise root cause analyses and provide detailed corrective and preventative
action plans which will include QMS activities.
Common findings from regulatory inspections
Final discussion session
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he 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.