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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