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.
The course will be split over four sessions as follows in UK time:
Tuesday, April 16 | 1.30pm – 5.30pm BST
Wednesday, April 17 | 1.30pm – 5.30pm BST
Tuesday, April 23 | 1.30pm – 5.30pm BST
Wednesday, April 24 | 1.30pm – 5.30pm BST
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.
The course will be split over four sessions as follows in UK time:
Tuesday, April 16 | 1.30pm – 5.30pm BST
Wednesday, April 17 | 1.30pm – 5.30pm BST
Tuesday, April 23 | 1.30pm – 5.30pm BST
Wednesday, April 24 | 1.30pm – 5.30pm BST
