Event Date/Time: May 15, 2003
End Date/Time: May 16, 2003
Providing the step-by-step foundation for stability testing, this comprehensive training course outlines the issues and guidelines surrounding FDA and ICH regulatory requirements. Specifically, this course will help you improve your analytical performance by incorporating new technology and quality control methods to ensure compliance of stability testing. In-depth details of how to analyze and validate stability indicating methods and their test results are discussed. Learn strategies to better design and implement a compliant stability data program at your location. Discuss key statistical issues that best underline dynamic Bracketing and Matrix designs to ensure your analytical methods generate meaningful stability data. Sample 483’s are reviewed to learn common deficiencies and pitfalls to avoid. Practical techniques are reviewed to improve the integrity of your stability data and ensure that test results comply with FDA and ICH requirements. By the end of the two-day retreat, attendees will gain the skill set to interpret regulatory guidelines, design compliant bracketing and matrixing strategies and ultimately be prepared for an FDA inspection in your stability lab.