A Quality by Design Approach for Stability Testing
Event Date: March 26, 2013 at 02:00 PM EDT
Stability testing is a highly integral part of successful pharmaceutical product development and commercialization. The quality-by-Design (QbD) approach to drug release emphasizes a risk-based approach to stability backed by good stability testing programs. The results of stability studies then facilitate the establishment of effective critical processing parameters (CPP). Water activity is an important CPP that when used properly can ensure product stability by mitigating issues relating to API hydrolysis, crystallization’s effect on dissolution rates, caking or clumping of powders, and moisture migration. This 60-minute webcast will provide regulatory and practical insight in agreement with QbD stability-testing requirements as well best practices in analytical methods development and testing for water activity and moisture.

Key Learning Objectives:
• Learn how to implement quality-by-design (QbD) in your stability-testing programs.

• See how stability studies can facilitate a QbD approach to drug release and ensure product stability

• Gain best practices for testing for water activity and moisture, including how to mitigate API hydrolysis, crystallization’s effect on dissolution rates, caking or clumping of powders, and moisture migration.


Patricia Van Arnum

Executive Editor
Pharmaceutical Technology


Kim Huynh-Ba

Executive Director of Pharmalytik, Chair of the AAPS Stability Focus Group, Chair of the USP Good Documentation Practices Expert Panel, and President of the 2013 Eastern Analytical Symposium

Manuel Zahn
Managing Director
3R Pharma Consulting GmbH

Brady Carter
Research Scientist
Decagon Devices

This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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