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Stability is recognized as a critical quality attribute (CQA) in the drug development process. However, the cost of conducting full stability programs is significant. The ICH Q1D guideline provides a framework for reducing stability testing by applying bracketing and matrixing strategies, especially for stable drug products.
This live webinar will explore the principles of bracketing and matrixing, demonstrate practical strategies for reduced testing, and highlight key factors to minimize risks while maintaining compliance. Attendees will gain a clear understanding of how to apply Q1D concepts to optimize stability programs efficiently.
Learning Benefits
- Understand the concepts of bracketing and matrixing
- Learn when and how to apply reduced stability testing
- Discuss bracketing applications in practice
- Examine matrixing approaches per Q1D guidelines
- Identify key factors to minimize risks in reduced testing
Who Should Attend
- Quality Control
- Quality Assurance
- Validation Teams
- Research & Development
- Auditors and Compliance Professionals
Kim Huynh-Ba
Kim Huynh-Ba has over 30 years of experience in quality systems, analytical development, project management, strategic drug development, and stability sciences. She currently is the managing director and CEO of Pharmalytik. where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She also has provided support to build Quality Management Systems (QMS) for many clients in the US and abroad. From 2011-2013, she took a sabbatical from Pharmalytik to join the U.S. Pharmacopeia...
