Where:
 Novartis Pharma AG
  Training & Development
 Learning Center Horburg
 WKL-430.P.39
 Müllheimerstrasse 195
 CH-4057 Basel
 Hotel Information and Directions
 Map - Learning Center Horburg

 When:
 Wednesday, September 26, 2007
 Thursday, September 27, 2007

The Product Quality Research Institute (PQRI) is sponsoring a training course addressing best practices for orally inhaled and nasal drug products (OINDP) leachables and extractables (L&E) pharmaceutical development programs. The content of the course will focus on best practices for L&E, and will be based on the PQRI Recommendations "Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inahled and Nasal Drug Products" (posted on the web here). Open discussion with be encouraged.

Topics will include:

• Selection of Container/Closure System Components
• Safety Evaluation of Extractables and Leachables
• Analysis of Extractables and Leachables
• Characterization of Extractables and Leachables
• Evaluation of Special Case Compounds
• Control Strategies for Quality