Providing a step-by-step foundation for biotech stability testing, this comprehensive training course outlines the issues and guidelines surrounding your stability programs. Learn strategies to better design and implement a compliant stability data program at your location, including a successful LIMS and legacy system. Discuss key statistical issues that best underline dynamic Bracketing and Matrixing designs to ensure your analytical methods generate meaningful stability data. Sample 483s will be reviewed to learn common deficiencies and pitfalls to avoid. Learn practical techniques to improve the integrity of your stability data management and ensure its compliance to FDA and ICH requirements.

Registration required:

Yes

Free:

No