Two Day Pharmacovigilance QMS & Inspection Preparation Online Training Course: Principles, Approaches and Regulatory Expectations for the Pharmacovigilance QMS and Risk-based Audits

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Jan 15, 2024, 20:00 ET

DUBLIN, Jan. 15, 2024 /PRNewswire/ -- The "Pharmacovigilance QMS & Inspection Preparation Training Course" conference has been added to ResearchAndMarkets.com's offering.

Since the introduction of the new pharmacovigilance legislation in the EU, QMS and self-audits have become an increasingly important topics.

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 including clinical, pharmacovigilance, sales and marketing, IT and medical services.

This must-attend course will explain principles, approaches and regulatory expectations for the pharmacovigilance QMS and risk-based audits and has been designed to help in both the assessments of risk and the whole CAPA process. The highly participative programme will include a mix of presentations from our expert trainer, real life case studies and practical workshop sessions which will help consolidate learning.

Benefits of attending:

Explore pharmacovigilance quality management systems (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 plans
Discuss pharmacovigilance inspections and QMS activities

Who Should Attend:

QA representatives, EU QPPVs and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.

Key Topics Covered:

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 versus external audits
What needs to be audited
Which departments need auditing for safety?

QMS

QMS design
Quality cycles - expectations and deviations
Quality risk assessments
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

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

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 and telephone audits
Results and CAPAs
Inspection follow-up questionnaires
Follow-up inspections

Workshop session

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 CAPA 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 PV area
Allied findings in other departments
KPIs versus legislation
Variations in major authority inspections

Speakers:

Graeme Ladds
Director
PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme 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.

For more information about this conference visit https://www.researchandmarkets.com/r/sq8req

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