How to Manage an Audit and Inspection2018-12-14T13:01:42+00:00

Project Description

How to Manage an Audit and Inspection

Course overview

Venue: Novotel London West Hotel, Hammersmith, London

Date: 15 May 2019*

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

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.  It is not a course on how to carry out a PV audit.

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

Fees

Cost Per Delegate:

£387 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£595 + VAT Standard

(Standard Registration)

Download Course Programme

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Booking options

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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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