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Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies

2 April 2020 09:00 - 3 April 2020 17:00, Washington, United States


Introduction
This 2 day course is aimed at providing a holistic understanding of the challenges and issues associated with implementing an effective control strategy for all impurity types. It will examine key areas, specifically, impurity qualification, mutagenic impurities, elemental impurities, extractives and leachables and solvents. In each case, it will examine practical approaches through both case studies and practical exercises and in all instances provide clarity as to the current and emerging regulatory frameworks.

The course also looks at other impurity related areas such as shared facilities, both the guideline and recent Q&A document, finishing with a look to the future and the challenges associated with new modalities including Oligonucleotides and Antibody Drug Conjugates.
Speakers
Venue
Drinker Biddle & Reath

Drinker Biddle & Reath, 1500 K Street, NW., 11th Floor, Washington, DC 20005, United States

Organised by
Scientific Update Ltd
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