DUBLIN--(BUSINESS WIRE)--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.
Agenda:
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
