Biopharmaceutical & Pharmaceutical Stability Current Trends & Best Practices 2024 2025 (2343)

Topics

Critical Regulatory Requirements for a Stability Program
Regulatory Guidelines Governing Stability Testing Operations
ICH Guidelines for Stability: USA, EU, Japan, and Rest of World (ROW), A Detailed Review
Stability Role in Drug Development Process
Stability Documentation Requirements
Stability Study for Early Drug Development
Testing Considerations
Increasing the Efficiency of Stability Testing Studies
Ongoing Stability Testing - Requirements, Cost Effective Solutions and Potential Pitfalls
The Methodology for Calculating Stability and Release limits
Estimating Shelf Life and Post-licensure Stability Studies
Investigation of OOS and OOT Stability Results
Outsourcing Stability Studies - Achieving Successful Relationships and Outcomes
Implementation of a Flexible cGMP Complaint Stability Program for Phase I - III Studies
Stability Chambers
Temperature Monitoring During Transportation and Storage
Assessing the Stability of Amorphous or Semi-Amorphous Materials
Integrating Laboratory Information Management Systems to Optimize Stability Programs
Forced Degradation Studies of API s and Drug Products
Stress Testing of APIs and Drug Products
Overcoming Key Challenges in Stability Testing for Generics
Current Practices in Annual Vaccine Stability Studies

Biopharmaceutical & Pharmaceutical Stability Current Trends & Best Practices