Course Description:
Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing this impurity. This one-day course will provide attendees with an understanding of current regulatory guidelines and USP General Chapter <1469> Nitrosamine Impurities. The course will provide an overview of sources of nitrosamines including their formation from the presence of other impurities and how to eliminate or reduce levels of nitrosamines. Tools to assess and control nitrosamines in drug substances and drug products as well as in depth analytical procedures in USP <1469> including the use of the USP Reference Standard and precautions to be used during procedures will also be covered. The course will also address risk assessment methodology as per ICH9, control strategy development, calculation of nitrosamine limits as per ICH M7 as well as test method performance characteristics.Includes Japanese Subtitles
Upon completion of this course, you will be able to:
- Describe the background, scope and approach of USP <1469> Nitrosamine Impurities and applicable regulatory guidelines.
- Explain pathways and sources of nitrosamine formation along with risk assessment tools and a high- level process flow to develop control strategies.
- Describe how to select the appropriate analytical procedures based on test method performance characteristics for nitrosamine methods
- Discuss the proper use and handling of the USP reference standard in the respective analytical procedures.
- Identify factors which impact sensitivity and selectivity of methods.
- Summarize key considerations, challenges and method conditions along with sample and standard preparation of the four test methods described in USP <1469>
Who should participate:
- R&D manufacturers
- QC managers
- QC staff scientists (DS, DP)
- Excipient manufacturers
- Research scientists
- QA staff who authorize drug product release
The live version of this recording took place on June 15-16, 2021Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first. The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
コース概要