Accomplishments Successfully influenced the USP and ICH Q3D regarding the requirements and limits for Elemental Impurities for Large Volume Parenterals (LVP). This resulted in industry-wide global concurrence and reasonable limits for the analysis of elemental impurities in this type of product. Subject matter expert for over one thousand finished product and raw material specifications and accompanying analytical test methods.

Highlights:

• Project Management
• Quality Assurance
• Regulatory Affairs
• Research
• Support
• Regulatory affairs