Mar 08, 2018 - Mar 09, 2018
9:00 am - 5:00 pm
Sheraton Sand Key Resort Clearwater
1160 Gulf Boulevard
Clearwater Beach 33767
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.
Name: Hannah May
Organization: Scientific Update Ltd
Contact Address: Maycroft Place, Stone Cross, Mayfield, East Sussex, TN20 6EW, UK