This online 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.
This online course will take place over four live sessions on the following dates and times:
PDT: 6.30am-10.30am | CDT: 8.30am-12.30pm | EDT: 9.30am-1.30pm | GMT: 1.30pm-5.30pm | CET: 2.30pm-6.30pm
– Tuesday, April 14th
– Wednesday, April 15th
– Tuesday, April 21st
– Wednesday, April 22nd
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.
This online course will take place over four live sessions on the following dates and times:
PDT: 6.30am-10.30am | CDT: 8.30am-12.30pm | EDT: 9.30am-1.30pm | GMT: 1.30pm-5.30pm | CET: 2.30pm-6.30pm
– Tuesday, April 14th
– Wednesday, April 15th
– Tuesday, April 21st
– Wednesday, April 22nd
