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Short Course

Course Information
Course Title: Stability Testing of Pharmaceutical Products
Categories: 1 - Laboratory Information and Management
2 - Liquid Chromatography
3 - Pharmaceutical Sciences
4 - Quality/Regulatory/Compliance
5 - Validation
Instructor(s): Kim Huynhba/Kathleen Vo Brady Course Number: 49
Affiliation: Pharmalytik
Course Date: 03/17/2013 - Sunday Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/18/2013 - Monday    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $925 ($1325 after 2/18/13) Textbook Fee: $157 Same text for Course #50

Course Description
Stability is a Critical Quality Attribute (CQA) in pharmaceutical development, thus a sustainable stability program is critical to new pharmaceutical product registration. This course presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products as applied in designing stability programs from early stages of product development to commercialization. Technical and regulatory aspects to design a global stability program which are cost effective and in compliance will be discussed in depth with the needs for stability-indicating methods to monitor product quality throughout its shelf life. Data management and Out-of-Spec/Out-of-Trend Investigation will also be discussed. This course will be taught by the editor of two well-known Stability Handbooks. Textbook recommended: Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices, Kim Huynh-Ba (ed.), ($179, Springer, 2008).

Target Audience
Analytical Chemists, QA/QC engineers, validation engineers, R&D scientists, Regulatory scientists, Quality Assurance, Manufacturing, lab managers, lab supervisors, lab directors, and everyone who would like to have a better understanding of stability science. This course requires at least two years of pharmaceutical analysis or drug development experience.

Course Outline
1. Introduction and Areas of Discussion
2. Regulatory Requirements of Stability Testing
3. Best Practices on Stability Operations and Global Requirements
4. Bracketing and Matrixing Strategies for Stability Programs
5. Stability Indicating Test Procedures
6. Evaluation of Stability Data and Reports
7. Out-of-Spec investigation for Stability Results
8. Interactive Discussion of Observations and Problem Solving

Course Instructor's Biography
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology teaching pharmaceutical analysis and analytical chemistry graduate courses. Kim is a member of AAPS Publication Committee, she was a member of USP General Chapter Expert Committee (2010-2015), and participated in the USP Reference Standard Project Team (2008-2010), and USP Prescription/Non-Prescription Stakeholder Forum. She is also a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. She is the chair of the Stability Focus Group and on several steering committees such as CMC, Pharmaceutical Trace Impurities and Contract Research Organization. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. Kim is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award. Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, in the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). Kathleen Brady, Sr. QA Engineer is an accomplished member of the Quality unit with 15 years combined experience in Quality Control and Quality Assurance. Kathleen has held several technical and quality positions and currently oversights the stability program at Actavis (formerly Watson Pharmaceuticals). Her expertise includes Out of Trend/OOS investigations, analyzing quality issues, designing process improvement, and trend analysis. Kathleen obtained her BS degree in Chemistry from University of California, Irvine. She is also an ASQ Certified Quality Engineer.