The Center for Professional Innovation & Education, Malvern, PA
March 2 & 3, 2010
Who Should Attend Because of its comprehensive content, this course will be valuable to personnel in stability, research and development, regulatory affairs, manufacturing, quality assurance, and the quality control laboratory, who are involved in conducting, supervising, or managing stability testing. This includes those whose job responsibilities require an in-depth knowledge of the FDA regulations and ICH guidelines as applied to establishing stability programs and conducting stability testing.
Learning Objectives Providing a step-by-step foundation for determining product shelf life through stability testing, this comprehensive training course outlines the issues and guidelines surrounding FDA and ICH regulatory requirements. Specifically, this course will focus on establishing a successful stability program through in-depth discussions on writing and revising stability protocols, stability sample management, stability indicating assays, out of specification results, and deviations. Sample 483s are reviewed to better understand typical deficiencies and how to avoid them. Practical techniques are reviewed to improve the integrity of the stability data and ensure that test results comply with FDA and ICH requirements. By the end of the two-day course, attendees will gain the skill set to interpret regulatory guidelines, design compliant stability program, and effectively prepare for an FDA inspection in their stability testing laboratory and sample storage facility.
Course Description
This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program.
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