Pharmacovigilance QMS & Inspection Preparation Course (London, United Kingdom - November 22-23, 2018) - ResearchAndMarkets.com
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.
The audit basicsThe 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 auditsThe 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 reportThe audit scope and conduct The audit report content The grading of audit reports Corrective action plans (root cause analysis) Re-audits
Introduction to PV inspectionsBackground Purpose - design Roles and responsibilities of the licence holder Conduct of regulatory inspections
Risk-based inspectionsDefining risk Routine and for cause inspections Triggers for an inspection Who should attend the inspection
The pharmacovigilance inspection cyclePre-inspection questionnaires Site visits & telephone audits Results and CAPAs Inspection follow up questionnaires Follow up Inspections
Common findings from regulatory inspectionsGrades 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 sessionFor 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/
Laura Wood, Senior Manager
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Related Topics:Drug Discovery
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
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PUB: 09/24/2018 08:55 AM/DISC: 09/24/2018 08:55 AM