6th Annual Stability Testing Conference

Venue: Holiday Inn Somerset

Location: Somerset, New Jersey, United States

Event Date/Time: Mar 23, 2010 End Date/Time: Mar 24, 2010
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Conference Topics

* Regulatory Requirements for Stability Testing - FDA, Health Canada, WHO and ICH Guidelines; Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B
* Stability Studies and the Product Life Cycle
* Update on the WHO Stability Guideline
* How to Calculate Product Expiry after Excursions
* Designing and Implementing an Effective Commercial (Marketed products) Stability Program
* Requirements for Stability Testing - API and Formulation Impurities
* Stress Testing of APIs and Drug Products
* Stability Indicating Profile for Biotechnology Products: Considerations for Development of Stability Testing Program for Biopharmaceuticals
* Vaccine Shelf Life and Post-licensure Stability Studies
* Implementation of the WHO Guideline on Stability Evaluation of Vaccines
* The Methodology for calculating Stability and Release Limits
* Setting Specifications for Drug Products
* Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs
* Quality by Design (QbD) and Stability Testing
* Q1E – ICH Harmonised Tripartite Guideline – Evaluation for Stability Data
* Using Practical Statistics to Interpret Stability Results
* Stability Challenges of Biologics
* Forced Degradation Studies Predict Effects on Bio-products in Drug Development and Manufacture
* Use of Statistics to Establish a Stability Trend – Matrixing & Bracketing
* Stability Testing in Challenging Storage Environments
* Stability Challenges of OTCs, Nutraceuticals and Combination Products
* Post Marketing Stability Evaluation
* Evaluating Product Quality After a Temperature Excursion


195 Davidson Avenue
New Jersey
United States