7 December 2016
Webinar - ICH Q3D: Practical implementation and the role of excipient data in a risk based approach
Dr. Andrew Teasdale, Impurities Advisory Group Chair at AstraZeneca, presented this webinar.
ICH Q3D: Practical implementation and the role of excipient data in a risk based approach
ICH Q3D advocates the use of a risk based approach to the assessment of the risk posed by elemental impurities. A major challenge in adopting such an approach is in balancing the need to generate data through testing against the potential use of existing knowledge. This talk looked to examine this challenge, focusing on how the increasing knowledge and understanding being gained through the advent of an excipient database can help address this.
William Nye, Account Manager at Lhasa Limited, also gave a demonstration of the Elemental Impurities Database.
See below for links to the recordings.
Headline Event (shown first above featured)
- Demonstration of the Vitic Elemental Impurities Database
- ICH Q3D: Practical implementation and the role of excipient data in a risk based approach