PPAR Presentations
PPAR 2014
GSK, PA
Meeting Overview
The 2014 PPAR meeting hosted by GSK included discussion around model validation and maintenance, method transfer, standards preparation, parallel testing, regulatory interaction, big data and lifecycle management, rapid microbiological and biological methods, disposable sensor guidelines, electronic data exchange standardization, continuous drug product manufacturing, and software backward compatibility for PAT and modeling.
Discussion Focus
- Model validation, maintenance, method transfer, and standards preparation
- Parallel testing
- Live meeting with Christine Moore, FDA
- Big data on lifecycle management
- Rapid microbiological and biological methods
- Disposable sensor guidelines
- Standardization of electronic data exchange formats between suppliers and pharma
- PAT considerations for continuous drug product manufacturing
- Backward compatibility of software for PAT and modeling, including regulatory implications
Available Materials
Materials are not currently available for this year.
Key Topics
- Model validation
- Method transfer
- Standards
- FDA interaction
- Lifecycle management
- Rapid micro methods
- Biological methods
- Disposable sensors
- Data exchange
- Continuous manufacturing
- Software compatibility
- Regulatory implications