The Public Health and Safety Organization
The Public Health and Safety Organization
N-nitrosamines are a regulatory and industry hot topic and whilst the focus has been on marketed products rather than development portfolios, there is an impact on investigational medicinal product development and manufacture. Led by expert Paul Cummings, this free NSF webinar introduces the topic of what needs to be considered during development of an IMP, the risks of delaying a formal risk assessment and the potential commercial impact, with the ultimate aim of a safe and efficacious product being granted a marketing authorisation.
This webinar explains what you need to consider when performing a nitrosamine risk assessment and covers a background on nitrosamine in products, active ingredient risks and contamination risks from water, solvents and cross contamination.
Learn moreNSF offers a complimentary self-assessment questionnaire that will provide you with a high-level estimate of your nitrosamine risk exposure.
Learn moreWhether it’s consulting, training, auditing, remediation, quality systems or regulatory guidance, NSF has you covered with our robust service offerings.
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