Pharmaceutical & Biopharmaceutical Stability 2011

Key Topics

• Stability Protocol Development to Meet International Product Registrations
• Regulatory Requirements of Stability Testing
• WORKSHOP Operational Excellence In Stability Storage Operations
• Designing Stability Program for Combination Products
• Herbal Medicinal Products - The Challenges of Stability Testing
• Challenges in Stability Testing - A European Perspective
• How to deal with Out of Specification Results (OOS) and Trends of Stability Data
• Development of Analytical Methods for Stability Testing
• Statistics in the Interpretation of Stability Results
• Successful Outsourcing of Stability Testing
• Using Stability Test Results for Expiry and Retest
• Calculation of Stability and Release Limits
• Follow-up Stability Testing
• Investigation Related to Stability Results
• Defining Bracketing and Matrixing (ICH Q1D)
• Post-Approval Changes (Variations) Requiring Stability Data
• Specific Stability Requirements for Biopharmaceuticals
• Planning Stability Testing to Cover a Product Lifecycle
• Drug Stability: Where to Draw the Line?
• Microbiological Testing during Stability Studies
• CASE STUDY Establishing a New Stability Program

Who should Attend

Executives and managers from Biopharmaceutical, Pharmaceutical, Biotech and Allied industries with responsibilities in Analytical R&D, Stability, Quality Assurance, Quality Control, Product Development, Raw Materials Testing, Chemistry, Manufacturing and Controls (CMC), Formulation, Pre-Clinical Research, GMP/GLP Compliance, Validation, Regulatory Affairs, Training, Product Submission, Contract Laboratories, Documentation and Technical Writing and Contract Manufacturing.