How to Manage Audits and Inspections (Online)

Course Overview

As companies implement partner audit programmes and more regulatory authorities initiate inspection programmes, the number of audits and inspections required only continues to increase. As these activities become more time consuming and complex, it is vital that colleagues involved in the management of the audit or inspection have an understanding of what is required and why. This training session will help to increase your understanding of the key feature of audits and inspections and discuss what makes an audit/inspection run successfully, regardless of the findings.

Who should attend

This course is aimed at:

• Pharmaceutical industry personnel from all areas that may be involved in pharmacovigilance inspections including pharmacovigilance staff at all levels, and quality and compliance teams

How our courses work

This is a one-day course which will involve:

• A combination of lectures and opportunities for discussion
• Examples of best practice and information based on current experience
• Full access to PDFs of the presentations afterwards
• Use this course as part of your Continuing Professional Development (CPD)
• Delegates will be sent a link in advance to enable you to join the live course at the stated time

Aims of the course

• To understand why audits and inspections are performed and the roles of the personnel involved
• To provide practical advice on management of audits and inspections, to help these run smoothly regardless of the outcome
• To explore the actions required after an audit or inspection and how to ensure an effective response and management of response to findings.

Learning outcomes

Key topics

Programme features:

• Different types of audit and inspection, including the key features and scope of each
• The service provider perspective on audit and inspection
• Practical planning and logistics
• Hints and tips on interviews
• The regulators perspective
• Differences in approach between different global regulatory authorities
• Post audit or inspection activities and their management

Our fees

Please note, VAT is only applicable for delegates based in the UK. Registration fees include electronic access to all course materials.

Cost Per Delegate:

• Academic

  £476

• Standard

  £309

Book now

• 13 September 2023

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  UK Based International

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