Managing GMP Compliance

Course Overview

The revision of Chapter 1 (Quality Management) and Chapter 2 (Personnel) of Part I of the EU guide to GMP to incorporate ICH Q10 brings into sharp focus the management responsibilities for implementation and assessment of quality systems within an organisation. Most notably the changes specify Senior Management responsibilities for quality.

This stimulating workshop is designed to make delegates think about where such responsibilities lie within their own organisation and the potential reputation and cost consequences of non-compliance.

Starting with a brief consideration of the key elements of the proposed revisions to the GMPs, the course moves through a series of case study scenarios and the consequent implications. Potential approaches to discharge management responsibilities are explored.

Suitability

This workshop is a must for anyone with responsibility for ensuring GMP compliance within their organisation including those at senior management level.

Learning Outcomes

By the end of the course you will:

• Understand the potential impact and cost to a company of non-compliance

• Understand the applications of risk management reviews to drive actions to achieve andmaintain GMP compliance

• Appreciate the importance of ownership to ensure compliance

• Realise the benefits of effecting a ‘quality culture’

As a public programme the course uses hypothetical scenarios built around common issues observed by auditors and regulatory authorities. Many companies find it can be even more effective run as an ‘in-house’ course, tailoring the case studies around their own specific audit findings, and engaging personnel from different levels within the organisation.