PPAR Presentations
PPAR 2004
Genentech, South San Francisco, CA
Meeting Overview
The 2004 PPAR materials reflect a formative period of PAT definition, regulatory development, and organizational benchmarking. Discussion areas included FDA PAT Guidance, international regulatory perspectives, benchmarking of PAT/PAC organizations, biotech manufacturing technologies, student training, and vendor audit practices.
Discussion Focus
- FDA PAT Guidance
- International regulatory perspectives
- PAT/PAC organization benchmarking
- Biotech manufacturing technologies
- Student training
- Vendor audit practices
Available Materials
Benchmarking
Regulatory / FDA
Biotech / Process Monitoring
Workforce / Training
Vendor / Standards
Key Topics
- FDA PAT Guidance
- Benchmarking
- Biotech manufacturing
- Regulatory strategy
- Vendor audits
- Student training
- PAT organization