Session: Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle

As the FDA and the pharmaceutical industry work together to embrace the shift of pharmaceutical quality regulation towards Quality-by-Design (QbD), a significant effort was made in the aspect of introducing a risk-based approach to pharmaceutical quality paradigm. The session will feature both invited and submitted papers presenting real world case examples on quality risk management over the product life cycle. Talks providing case studies successful experiences, and lessons learned, and to discuss the benefits and challenges associated with applying risk management principles over the product life cycle in the pharmaceutical community are targeted.