The revision of Chapter 1 (Quality Management) and Chapter 2 (Personnel) of Part I of the EU guide to GMP to bring it in line with ICH Q10 will mean an increasing regulatory focus on senior management responsibility for quality within an organisation. This stimulating workshop is designed to make delegates
think about where such responsibilities lie within their
own organisation, and poses the important question of the 'Cost of Quality' versus the 'Cost 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. Potentially business critical situations are explored to identify root causes and effective remedial and preventive actions.
think about where such responsibilities lie within their
own organisation, and poses the important question of the 'Cost of Quality' versus the 'Cost 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. Potentially business critical situations are explored to identify root causes and effective remedial and preventive actions.
