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IIR PTI
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| CMC Analytical, Comparability and Stability Studies for Biotechnology Products |
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Thu 25 Mar 2010
- Fri 26 Mar 2010
Regus St. James's Park, London, United Kingdom
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Thu 14 Oct 2010
- Fri 15 Oct 2010
Regus Trafalgar Square, London, England
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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.
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“Well presented relevant topics, in a relaxed atmosphere”
Michael Mayo, Support Function Manager, Amersham
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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
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Course Leader
Nadine M. Ritter, Ph.D. Senior CMC Consultant, Biologics Consulting Group. Inc.
Nadine is a biotechnology product consultant who s p e c i a l i ses in the development and validation of analytical methods, the design and execution of product stability p ro g rams and the establishment of quality practices in l a b o ratories ranging from R&D through cGMP. She has technical and re g u l a t o ry expertise in a wide variety of recombinant and transgenic proteins, antibodies, synthetic peptides, blood products, viral vectors and vaccines
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