Presented by
Management Forum

Pharmacovigilance QMS & Inspection Preparation

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

18-19 Nov 2021 + 2 more dates

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  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

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 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, reallife 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.

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The Pharmacovigilance QMS & Inspection Preparation course will cover:

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

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Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he 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.

More details

Book Pharmacovigilance QMS & Inspection Preparation Live online training

18-19 Nov 2021

Live online

09:00-16:15 UK (London) (UTC+00)
10:00-17:15 Paris (UTC+01)
04:00-11:15 New York (UTC-05)
Course code 11060

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

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23-24 May 2022

Live online

09:00-16:15 UK (London) (UTC+01)
10:00-17:15 Paris (UTC+02)
04:00-11:15 New York (UTC-04)
Course code 11627

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 18 Apr

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16-17 Nov 2022

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
19:00-19:00 New York (UTC-05)
Course code 11768

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 12 Oct

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Reviews of IPI's Pharmacovigilance QMS & Inspection Preparation training course


The speaker was excellent and gave very practical examples of what is looked for in an Audit

Nov 19 2020

Kathleen Dunphy
Senior Administrator , NorthStar Healthcare

Nov 11 2019

I wanted to reinforce my knowledge and I definitely accomplished this. Graeme Ladds was great as usual. His pharmacovigilance knowledge is extensive, any question was answered confidently and debate was encouraged.

Christopher Harper
Senior Medical Information Manager, Astellas Pharma Europe Ltd

Nov 11 2019

The course actually exceeded my expectations and gave me an inside view of flaws in my PhV system. Great speaker with a lot of knowledge, good pace and experiences/stories from real life.

Hrvoje Sarec
Pharmacovigilance Specialist, Xellia d.o.o.

Nov 11 2019

Excellent presentation by a very experienced speaker. The examples provided and the exercises were greatly appreciated.

Anne-Elisabeth Collignon
Pharmacovigilance Head of PV Quality Assurance, Institut de Recherches Internationales Servier

Nov 11 2019

The speaker was very knowledgeable and easy to approach and I would definitely attend another course that had him as trainer. The practical examples were very useful and the course was interesting, well organised, and had a good balance in terms of content and difficulty.

Claudia Percivalle
Head of Global Regulatory Affairs, Cycle Pharmaceuticals Ltd.

Nov 11 2019

The speaker was very very good and I particularly liked the opportunity to exchange experiences and examples.

Evangelia Tsakiraki
EU QPPV, Piramal Critical Care B.V.

Nov 22 2018

Very interactive and interesting the speaker has a great knowledge of the subject and respond to all our queries.

Tracy Salamoun
Regulatory affairs Associate , Union pharmaceutique d’orient sal

Nov 22 2018

A very well knowledgeable presenter in QA and particularly in PV. The content was rich and touched all areas in great detail. The course is very well balanced and anyone (junior to experienced) in QA could understand and learn from the training.

Netsanet Desta-Evers
Clinical Safety Compliance Specialist, Novimmune SA

Nov 22 2018

[The speaker] was good :) Overall, it was a good class!

Jiwan Park
QA Associate, Celltrion

UK

  • Allergan
  • Amicus Therapeutics
  • Astellas Pharma Europe Ltd
  • Creo Pharma
  • Creo Pharma Ltd
  • Cycle Pharmaceuticals Ltd.
  • Grunenthal Ltd
  • Nelsons

Ireland

  • Chanelle Pharmaceuticals Manufacturing Ltd
  • NorthStar Healthcare
  • PTC Therapeutics, Inc.

Spain

  • FAES FARMA
  • FAES FARMA SA
  • Ferrer Internacional

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Xellia d.o.o.

France

  • INNATE PHARMA
  • Institut de Recherches Internationales Servier

Germany

  • CSL Behring GmbH
  • Fresenius Kabi Deutschland GmbH

Czech Republic

  • Arriello sro

Italy

  • L. MOLTENI & C.

Korea, Republic Of

  • Celltrion

Lebanon

  • Union pharmaceutique d’orient sal

Netherlands

  • Piramal Critical Care B.V.

Slovak Republic

  • Ewopharma International

Switzerland

  • Novimmune SA

United States of America

  • MEI Pharma

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy