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.
