Editors’ Series: Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis
The discovery of nitrosamine-based impurities in APIs has triggered recalls of commonly used drugs and placed the quality of the drug supply in question. Learn best practices for identifying impurities in drug substances and drug products and the roles and responsibilities of ingredients suppliers, drug manufacturers, and regulatory authorities. Live:Tuesday, Jul. 14, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On Demand: available after airing until Jul. 14, 2021 Register free
Register free: http://www.pharmtech.com/pt_w/lessons
Event Overview:
The discovery of genotoxic contaminants in commonly used prescription and OTC medicines over the past two years triggered expensive recalls and raised important questions about the safety of drug ingredients, testing procedures, and the supply chain for tracking materials and finished drug products. Public health questions remain unanswered.
In this Pharmaceutical Technology Editors’ Series webcast, experts share best practices for identifying impurities and experiences with testing, and discuss the roles and responsibilities of ingredients suppliers, drug manufacturers, and regulatory authorities.
Key Learning Objectives:
- Trace the discovery of genotoxic impurities in the global drug supply
- Understand the gaps in quality control and regulatory oversight that led to the contamination
- Understand analytical processes to identify and track contaminants in drug substances and drug products.
Speakers:
David Light, CEO, Valisure
Ron Najafi, CEO, Emery Pharma
Ed Gump, PhD, Vice President, USP Science-Small Molecules
Time and Date: Tuesday, Jul. 14, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
On demand available after airing until Jul. 14, 2021.
Sponsors: AMRI, SCIEX, USP
Register free: http://www.pharmtech.com/pt_w/lessons
