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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 and maintain GMP compliance
Appreciate the importance of ownership to ensure compliance
Realise the benefits of effecting a ‘quality culture’
