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.

Who Will Attend?
• QA/QC Manager /Director • (Pharmaceutical) Development Manager • Section Leader • Chemist • Laboratory Supervisor • Stability Team Leader • Scientific Officer • Executive • First Line Manager • Stability Studies Manager • Regulatory Affairs Officer • Analytical chemist Technician • Technical support Manager • (Commercial) Stability Analyst • Stability Co-ordinator • Lab Services Manager • Business Development Manager • Regulatory Pharmaceutical Assessor

Course Leader
Nadine M. Ritter is a biotechnology product consultant who specialises in the development and validation of analytical methods, the design and execution of product stability programs and the establishment of quality practices in laboratories ranging from R&D through cGMP. She has technical and regulatory expertise in a wide variety of recombinant and transgenic proteins, antibodies, synthetic peptides, blood products, viral vectors and vaccines

Registration required:

Yes

Free:

No