Biopharmaceutical & Pharmaceutical Stability Current Trends & Best Practices

March 23 - 24, 2010(Ended)
Jersey City, NJ, United States
Biopharmaceutical & Pharmaceutical Stability Current Trends & Best PracticesTopics

  • 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
Venue
Not final
Address
Jersey City,

New Jersey,

United States
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