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Development and Manufacture of Effervescent Tablets
Thermal Methods and Calorimetry - applications and practical help
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Stability Testing in Pharmaceutical Development and Manufacturing (2 day)
| Type | Training - Paid |
|---|---|
| Language | English |
| Date |
December 12, 2011
to December 13, 2011 |
| Venue |
Window Conference Venue 13 Windsor Street Islington, London N1 8QG GB |
| Chemistry Specialties |
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| Chemistry Techniques |
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| Contact |
Judy Callanan PharmaTraining Limited BioCity, Pennyfoot Street Nottingham, NG1 1GF GB 44 (0) 115 9124249 44 (0) 207 6813582 judy@pharma-training-courses.com |
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New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, through improved methods of shelf life prediction and excipient testing. New stability testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably. The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment: Why is stability testing required for product registration and GMP purposes? What are the requirements for Clinical Trials, new, and existing products? How can stability testing be applied during product development to shorten development times as well as improve product quality Stability testing outsourcing - successful management and execution It will include: A comprehensive review of ICH stability testing guidance ICH Q1A Pitfalls in stability testing. Outsourcing—costs and benefits New approaches to stability testing including ASAP and the role of peroxides in product stability Stability Testing and QbD Workshops for attendees to present and discuss their own stability testing issues with the group