Pre-Conference Workshop Day: Monday 24 May 2010

14:00 - 17:00 Workshop A: Establishing A QbD Principal from Scratch: Where to Start?

Part 1: Informal presentations by both speakers

• Highlighting the regulatory background
• Overview of QbD framework
• Discussiob of case studies to demonstrate the power of QbD principles for recombinant proteins, vaccines and cell based medicines
• Tools you can use to assign ‘Criticality’ to Process Parameters (CPPs) and Quality Attributes (CQAs)
• Understanding the process using DoE to establish the multivariate interactions between CPPs and CQAs
• Control strategy to assure process performance and product quality

Part 2: Interactive huddles

• Use of risk assessments to screen for CPPs
  • Ishikawa
  • FMEA
• Group assessment of the practical challenges in implementing QbD for biologics

Workshop Facilitators: