Pharmacovigilance QMS & Inspection Preparation Course (London, United Kingdom - November 22-23, 2018) - ResearchAndMarkets.com

September 24, 2018

DUBLIN--(BUSINESS WIRE)--Sep 24, 2018--The “Pharmacovigilance QMS & Inspection Preparation” conference has been added to ResearchAndMarkets.com’s offering.

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 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, 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 Pharmacovigilance workers Regulatory Clinical administrators Those responsible for the management of the CAPA systems.


Day One

The audit basics

The purpose of an audit Qualifications of the auditor The audit SOP & design The difference between audits and inspections Audit planning and risk assessments

The legislation and audits

The requirements to perform company audits In-house versus external audits What needs to be audited Which departments need auditing for safety

Quality Management Systems (QMS)

Quality Management Systems - design Quality cycles - expectations and deviations Quality risk assessments Key Performance Indicators (KPIs) Quality failings and corrections

QMS and the audit report

The audit scope and conduct The audit report content The grading of audit reports Corrective action plans (root cause analysis) Re-audits

Workshop session

Day Two

Introduction to PV inspections

Background Purpose - design Roles and responsibilities of the licence holder Conduct of regulatory inspections

Risk-based inspections

Defining risk Routine and for cause inspections Triggers for an inspection Who should attend the inspection

The pharmacovigilance inspection cycle

Pre-inspection questionnaires Site visits & telephone audits Results and CAPAs Inspection follow up questionnaires Follow up Inspections

Workshop session

Common findings from regulatory inspections

Grades of findings (how to grade findings) How to grade findings in the same PV area Allied findings in other Departments KPIs versus legislation Variations in major authority inspections

Final discussion session

For more information about this conference visit https://www.researchandmarkets.com/research/3g955p/pharmacovigilance?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180924005531/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager


For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Drug Discovery



SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 09/24/2018 08:55 AM/DISC: 09/24/2018 08:55 AM


Update hourly