Event Date/Time: Feb 11, 2008 End Date/Time: Feb 12, 2008
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Description

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
Stability
- Current issues on Stability Zone III and IV
Conditions
- 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 -
Chambers
- 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
Studies
- cGMP Requirements on Data Reporting
- Interpretation of Temperature Monitoring
Data
- Managing Stability Data to Ensure Quality
- Designing and Formatting Summary Reports
- Automating Data Review and Approval

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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