ResearchandMarkets.com is offering a “Pharmacovigilance QMS & Inspection Preparation” course in London, May 14–15, 2020, designed to help attendees understand pharmacovigilance quality management systems (QMS) and risk-based audits.
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 continuous improvement of processes, systems, and compliance to regulations needs to be demonstrated. This is required from the top of the company organization in all areas of regulatory activity including clinical, pharmacovigilance, sales and marketing, IT, and medical services.
This course is designed to help in both the assessments of risk and the entire corrective and preventive actions (CAPA) and preventative action elements.
Benefits of attending
- Understand the pharmacovigilance 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 and preventive actions
- Discuss pharmacovigilance inspections and QMS activities
Who should attend?
QA representatives, EU Qualified Person Responsible for Pharmacovigilance (QPPVs), and all working in pharmacovigilance, regulatory, clinical, and administrators 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 and design
- The difference between audits and inspections
- Audit planning and risk assessments
The legislation and audits
- The requirements to perform company audits
- In-house vs. external audits
- What needs to be audited
- Which departments need auditing for safety
- QMS design
- Quality cycles—expectations and deviations
- Quality risk assessments
- 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)
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.
Agenda, day two
Introduction to pharmacovigilance inspections
- Roles and responsibilities of the license holder
- Conduct of regulatory 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 and telephone audits
- Results and CAPAs
- Inspection follow-up questionnaires
- Follow-up inspections
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 preventive
action plans which will include QMS activities.
Common findings from regulatory inspections
- Grades of findings (and how to grade findings)
- How to grade findings in the same pharmacovigilance 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/r/nrivp3.