10times
11 May 2021Ended

Ensuring stability excellence for global consumer and OTC products

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upto 100
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Based on previous editions

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May 2021

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The International Council on Harmonisation - Quality (ICH Q1A) guidance exists to support companies in maintaining a rigorous approach to stability .. Read more testing. In this webinar, we will explore the detail of ICH Q1A and explain how to meet its requirements. Explore current global regulatory requirements on stability testing by USFDA, ICH, EU, ANVISA and APAC 4. Explain the different stability testing approaches for drug products containing multiple APIs with different strength and SKUs 5. Advise on temperature cycling, freeze-thaw and shipping studies Drug companies can ensure the success of their stability testing programme by working closely with partners who have specialist testing capabilities and study management experience. In addition, a case study from a major stability programme will also be presented during the webinar, offering a real-world example of best-practice stability testing. With 26 years in the pharmaceutical sector, including 15 years developing products for CDMO companies, Maria is responsible for leading Recipharm’s drug product development team, as well as heading up our formulation and analytical development operations globally.

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