In this webinar, learn the background on nitrosamines, including factors that increase the risk of contamination in pharmaceuticals. Attendees will learn about recent scientific developments that have enhanced the requirements for risk assessment, testing and mitigation. The featured speakers will discuss regulatory guidance on assessing the risk of — and identifying the root cause for — potential nitrosamine impurities. Attendees will learn about the reporting and notification requirements for nitrosamines in pharmaceuticals. Attendees will also gain insights into the recent Food and Drug Administration (FDA) guidance on nitrosamine drug substance-related impurities (NDSRIs) and implementation requirements.
TORONTO, Oct. 9, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into nitrosamine contamination in drug manufacturing and the current scientific and regulatory landscape. Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks of nitrosamine contamination and potential genotoxicity.
Over the past five years, developments in process chemistry, analytical technology and regulatory guidances have shaped the state of play for nitrosamine impurities in drug manufacturing. In this webinar, the featured speakers will explore the current scientific and regulatory landscape for nitrosamines, highlighting the current requirements for assessing, controlling and monitoring their presence as contaminants in pharmaceuticals.
Topics in this webinar will include:
- Background on nitrosamines, including factors that increase the risk of contamination in pharmaceuticals
- Recent scientific developments that have enhanced the requirements for risk assessment, testing and mitigation
- Regulatory guidance on assessing the risk of — and identifying the root cause for — potential nitrosamine impurities
- Reporting and notification requirements for nitrosamines in pharmaceuticals
- Recent Food and Drug Administration (FDA) guidance on nitrosamine drug substance-related impurities (NDSRIs) and implementation requirements
Join this webinar to gain insights into nitrosamine contamination in drug manufacturing and the current scientific and regulatory landscape.
Join experts from Premier Consulting, Dr. Olu Aloba, Vice President, CMC Services; and Dr. Marianthi Karakatsani, Director, CMC Development Strategy, for the live webinar on Thursday, October 19, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit 2023 RAPS Article of The Year: Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals.
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