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 organization. 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 organization 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.
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 organization. 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 organization 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.
