QUALITY BY DESIGN

Conference Date: 15 Oct 2009-27 Nov 2009
Conference Ref: M10-6109
Fee: £1260 + VAT
Venue: Harrington Hall Hotel, London

The Focus of this meeting will be:

• Putting ‘QbD’ in context - EU, US and Japan
• Background and relevance of ICH Q8/Q9/Q10
• Key QbD philosophies from Quality Target Product Profile to Continual Improvement
• Risk Management
• Role of Subject Matter Experts and cross function working
• Practical understanding and links between Critical Quality Attributes, Critical Process Parameters and Material Attributes for both Drug  Substances and Drug Product
• Design Space
• Control Strategy
• Real Time Release
• PAT Tools enabling QbD - Process Analyers, Design of Experiments, Multivariate Analyses
• Pharmaceutical Quality System and the link to GMP
• Making the Business case for QbD
• Regulatory implications of QbD
• Use of practical examples

To book your place on this important event, please click here