PPAR Presentations
PPAR 2011
Amgen, West Greenwich, RI
Meeting Overview
The 2011 PPAR meeting was hosted by Amgen on September 26–27 in West Greenwich, Rhode Island. The meeting focused on raw material variability, QbD-PAT control strategy, regulatory updates, PAT data management, IT infrastructure, MVDA across the product lifecycle, continuous processing, technology gaps, new applications for small and large molecules, PAT benefits, PAT at contract manufacturing organizations, technology development strategies, process development lab tours, PAT demos, and sample-size determination.
Discussion Focus
- Raw material variability, raw material CQAs, and global supply chain
- QbD-PAT control strategy for CQAs
- Regulatory updates
- Data management for PAT and IT infrastructure
- MVDA across online, offline, and lifecycle use cases
- Continuous processing and the role of PAT
- New technologies and applications for small and large molecules
- PAT benefits, contract manufacturing, and technology development strategies
- Process development lab tours, PAT demos, and sample-size determination
Available Materials
- Continuous Processing / RTRT
- New Technologies — Small Molecules
- New Technologies — Large Molecules
- Control Strategy / CQAs / Regulatory
- Raw Material Variability / Supply Chain
- Data Management / IT Infrastructure / MVDA
- Business Case / PAT Benefits
Documents
Key Topics
- Raw material variability
- CQAs and QbD-PAT
- Control strategy and regulatory updates
- Data management, IT infrastructure, and MVDA
- Continuous processing and technology gaps
- Small molecules and large molecules
- PAT benefits and contract manufacturing
- Process development labs and sample-size determination