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Introduction to Photostability
A Practical Introduction to
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Stability Testing in Biological Product Development and Manufacturing (2 day)
| Type | Course |
|---|---|
| Language | English |
| Date |
December 12, 2011
to December 13, 2011 |
| Venue |
Window Conference Venue 13 Windsor Street Islington, London N1 8QG GB |
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| 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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Quality by Design principles are being applied throughout the pharmaceutical development process and stability testing is no exception. Stability testing of biological products presents specific challenges in respect of product type and characterisation, especially the complexity of both active substances and the products. This course covers all of the relevant regulatory, ICH and GMP guidance including stability study design and principles of QbD on Day 1. On Day 2, we look at the specifics of evaluating biological products, generation of stability data, specification setting and shelf life evaluation. The course will include: • Stability Testing and QbD • Why is stability testing required for product registration and GMP purposes? • What are the stability test 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 And • Biological product evaluation and analytical methods • Product characterisation • Setting specifications and shelf lives • Ongoing stability testing of biological products for product maintenance and GMP