Advances in Stability Testing (Advances in Stabilit)

Venue: Boston

Location: Boston, United States

Event Date/Time: May 10, 2011 End Date/Time: May 11, 2011
Early Registration Date: Mar 18, 2011
Report as Spam

Description

Program Outline:

Global Regulatory Requirements for Stability Testing
Update on Global Stability Program including ICH (Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B), FDA, Japan, EMEA, and WHO Guidelines
Stability Principles & Regulatory Considerations for Drug Substances and Drug Products
Stability Requirements for Global Regulatory Filings
Storage Conditions and Time Points to Satisfy Various Regulatory Filings
Stability Testing for Drug Substances and Drug Products
Stability Protocol Development to meet International Product Registrations
US, EU, and Japan
WHO
China
Southeast Asia
Australia
South Africa
Brazil
ICH and Rest of World Guidance Update
Non-ICH Region Requirements and Unusual Requests
Focus on the the difference between ICH, WHO and other regions
Development and Validation of Stability-Indicating Methods
Stability Indicating Methods to Monitor Potential Changes in Product Performance
Establishing Impurities Specifications for New Drug Products
Operational Excellence In Stability Storage Operations
Packaging Considerations
Statistical Tools for Stability Trending and Expiry Evaluation
Workshop on Designing Stability Programs For Early Stages of Development
OTC Stability Considerations
Combination Product Stability
Biotech Stability: A Different Stability Challenge
Commercial Distribution Studies
Photostability
Leveraging Data
Product Aging -Stability's Medical Device Shelf Life Cousin
Stability Chamber Validation, Calibration and Maintenance
Laboratory Information Management Systems for Stability Programs
Out of Specification/Out of Trend Investigations

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