How to Manage an Audit and Inspection2020-06-17T09:50:57+00:00

Project Description

How to Manage an Audit and Inspection 

Course overview

Venue: Novotel London West Hotel, Hammersmith, London

Date: May 2021

The number of audits and inspections is continuing to increase as all companies implement partner audit programmes and more regulatory authorities initiate inspection programmes.  As these activities become increasingly time consuming and complex, it is vital that those involved in the management of the audit or inspection have an understanding of what is required and why.

The course will provide you with an overview of the key feature of audits and inspections and discuss what makes a successfully run audit/inspection regardless of the findings. You will obtain practical information and advice on provider audit, the keys to preparing for and effectively managing inspection, as well as gaining insight into the roles and expectations of key personnel.  We will also consider differences between inspections in key global markets.

*Please note that the course dates and programme may be subject to change.

Who should attend?

This course is aimed at:

  • Pharmaceutical industry personnel from areas including pharmacovigilance, drug safety, medical affairs, clinical research and legal departments
  • Staff from regulatory authorities

How our courses work

  • Small class size allows for one-to-one interaction with expert tutors
  • A combination of short lectures, practical workshops and interactive discussion sessions
  • Taught by a panel of expert speakers (minimum of four speakers per course) from industry, regulatory bodies and academia
  • Course materials including presentations, workshop material and suggested reading documents are made available electronically during the course
  • The agenda provides ample opportunity to network with expert speakers and your fellow delegates

Lunch, refreshments and all course materials are included in the registration fee.

Aims of course

The course is intended for those with a basic understanding of pharmacovigilance (PV) audit and inspection to help to increase confidence and improve your management of these activities.

Learning Outcomes

  • Understand the key aspects of PV audit (internal audit, partner and provider audit) and inspection
  • Understand the do’s and don’ts for successful audit management
  • Be able to support and facilitate PV audit and inspection management within your organisations and departments

Key Topics

Programmed features:

  • Setting the scene: Internal audits, partner audit and inspection – the key features,  differences and scope of activities
  • Audit/Inspection for service providers
  • The role of the QPPV
  • Managing audit and inspection – planning and logistics
  • Audit/Inspection interviews
  • The Inspector’s view
  • Industry perspective on differences between inspections from various authorities (FDA, Europe, Japan)
  • After the Inspection: Initial feedback, CAPA management and tracking


Cost Per Delegate:

£387 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)


£595 + VAT Standard

(Standard Registration)

Registration fee includes lunch, refreshments and electronic access to all course materials.

Download Course Programme

Click here to download the programme


Booking options


“Vital and practical topics put together well”

Audits & Inspections delegate 2019

“I really enjoyed the course and found it useful in my daily work. Great presenters”

Audits & Inspections delegate 2019

“Well organised and timed. Lots of information from speakers with a lot of knowledge and experience”

Audits & Inspections delegate 2019

Course Leader

Elspeth McIntosh – Director

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance.  She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products.

Elspeth is now the Director of pharmacovigilance consultancy company, Castle Pharmacovigilance Ltd, providing PV support and working as a contract QPPV for small companies.  She has a MBA and a Post Graduate Diploma in Pharmacovigilance.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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