Friday, June 5, 2026; 1:30pm – 4:30pm
Half-Day Short Course at UCONN
Course Description:
This half-day course provides a comprehensive technical examination of the transition from ICH Q1A(R2) to the revised ICH Q1 framework issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The session analyzes structural consolidation of the Q1 series and key scientific shifts, including expanded climatic zone coverage, clarified intermediate storage conditions, modernization of bracketing and matrixing strategies, and strengthened statistical requirements for shelf-life extrapolation. Enhanced expectations for trend analysis, out-of-trend detection, and scientifically justified expiry dating are discussed in depth. The program also addresses increased emphasis on risk management, knowledge management, and lifecycle oversight beyond initial approval.
The second portion of the course focuses on practical implementation. Participants will conduct a structured gap assessment comparing legacy Q1A(R2)-based stability protocols against revised expectations. Areas evaluated include stability commitments, ongoing monitoring systems, statistical models, protocol design, data evaluation practices, and change management integration. The course provides a systematic methodology to prioritize remediation activities, align commercial stability programs with current regulatory standards, and strengthen inspection readiness through defensible, science-based stability strategies.
Learning Benefits
- Differentiate structural changes between Q1A(R2) and revised Q1 framework
- Interpret expanded climatic zone and storage condition expectations
- Apply updated bracketing and matrixing principles scientifically
- Evaluate strengthened statistical requirements for shelf-life extrapolation
- Detect and manage stability trends and out-of-trend signals
- Assess lifecycle oversight beyond initial marketing authorization
- Conduct structured gap analysis of commercial stability programs
- Develop prioritized remediation plan ensuring regulatory compliance alignment
About the Instructor:
Kim Huynh-Ba is the Managing Director of Pharmalytik (www.pharmalytik.com) providing consulting and training, specializing in quality systems, validation, CMC and stability sciences. She is a member of the US Pharmacopeia’s Council of Experts and the Chair of the Small Molecules Monographs 4 Expert Committee for the 2015-2025 cycle. She was a member of USP Organic Impurities Expert Panels. Kim is a member of the EAS Governing Board and their 2013 President. She is an adjunct professor at Temple University‐ RAQA Program and Illinois Institute of Technology teaching Pharmaceutical Analysis, Quality audit, ICH Quality Guidelines, and GMP. Kim authored over 80 technical publications and book chapters. She is the editor of the “Stability Handbook in Pharmaceutical Laboratories” and more recently the textbook of “Pharmaceutical Testing for the Pharmaceutical GMP Lab”.