DAY 1

Session 1: Overview of the Guidances

• Guidance: Genotoxic Impurities
• Guidance: Trace Metals Analysis
• Guidance: Foreign Particles in Inhaled Products

Session 2: Application of the Guidances

• Case Study: Handling of Genotoxic Impurities in Development
• Case Study: The Detection of Trace Metals
• Case Study: Control of Foreign Particles in Inhaled Products

Session 3: How low can/should we go

• Assessment of Physical Impurities using a Range of Solid State Techniques
• New NMR Approaches for the Detection and Identification of Impurities
• Soundbites of Practical Experiences of the Guidelines

DAY 2

Session 4: Workshop Sessions

• Cleaning Verification
• System Suitability

Session 5: New and Emerging Technologies

• Solid State Analysis by Atomic Force Microscopy
• UPLC: Finding Smaller and Sharper Needles in a Haystack
• Raman Spectroscopy: Applications to Pharmaceutical Development