Event Date/Time: Feb 11, 2008 End Date/Time: Feb 12, 2008
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How to Manage a Comprehensive and Effective Stability Program
Ensuring Global Regulatory Compliance & Best Practices in GMP

An Important Two-Day Comprehensive & Interactive Conference, with Discussions & Workshops on:

- Updates on ICH and WHO Guidance for
- Current issues on Stability Zone III and IV
- Developing Stability Protocols for Global
Product Registration
- Predicting "Real Time" Drug Stability and
Degradation Profiles
- Estimation of Remaining Shelf-Life after
Temperature Excursions
- ICH Q1D Guideline and Bracketing and
Matrixing Designs
- Applying Quality by Design (QbD) Principles
in Stability Studies
- Ensuring Regulatory Acceptance of Reduced
Study Design
- Qualification (IQ/OQ/PQ) of Environmental -
- Oxidative Susceptibility Testing
- Estimation of Remaining Shelf Life after
Temperature Excursions
- Establishing Shelf Life Formulation for
Clinical Trials Materials
- Analyzing Stability Data and Setting
Specifications for Biologics
- Comparability of Stability after a
Process/Facility Change
- Stability Studies for Clinical Product
- Design and Analysis of Annual Stability
- cGMP Requirements on Data Reporting
- Interpretation of Temperature Monitoring
- Managing Stability Data to Ensure Quality
- Designing and Formatting Summary Reports
- Automating Data Review and Approval


Additional Information

This two day program is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, Biotech, and allied industries with daily responsibilities in the following areas: - Stability - Analytical R&D - Quality Control - Quality Assurance - Raw Materials Testing - Product Development - Formulation - Chemistry, Manufacturing and Controls (CMC) - GMP/GLP Compliance - Pre-Clinical Research - Regulatory Affairs - Validation - Product Submission - Training - Documentation and Technical Writing - Contract Laboratories - Consultants - Contract manufacturing and other Compliance professionals