Presented by
Management Forum
Pharmacovigilance QMS & Inspection Preparation Training Course
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
★★★★★ "The speaker was excellent and gave very practical examples of what is looked for in an Audit"
23-24 May 2022 + 1 more date
- 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.
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
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.
Book Pharmacovigilance QMS & Inspection Preparation Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
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 1,299
- EUR 1,859
- USD 2,098
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
16-17 Nov 2022
Live online
Course code 11768
- GBP 1,099 1,299
- EUR 1,579 1,859
- USD 1,786 2,098
Until 12 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
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
United Kingdom
- Abbott Healthcare Products B.V
- Allergan
- Amicus Therapeutics
- Astellas Pharma Europe Ltd
- Creo Pharma
- Creo Pharma Ltd
- Cycle Pharmaceuticals Ltd.
- Grunenthal Ltd
- Nelsons
Spain
- FAES FARMA
- FAES FARMA SA
- Ferrer Internacional
- Insud Pharma
Germany
- CSL Behring GmbH
- Csl Behring Innovation GmbH
- Fresenius Kabi Deutschland GmbH
Ireland
- Chanelle Pharmaceuticals Manufacturing Ltd
- NorthStar Healthcare
- PTC Therapeutics, Inc.
Croatia
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
- Xellia d.o.o.
France
- INNATE PHARMA
- Institut de Recherches Internationales Servier
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
Run Pharmacovigilance QMS & Inspection Preparation Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
