N-Nitrosamines – Past, Present and Future Through the Eyes of an Analytical Chemist

Since the initial Valsartan contamination incident in 2018, the issue of N-Nitrosamines has continued to present major challenges for the pharmaceutical industry.  This webinar will seek to chart the evolution of the issue, from the initial concerns relating to formation of Nitrosamines during the synthesis of the drug substance, to the wider challenges of the risk of formation of Nitrosamine Drug Substance related impurities (NDSRIs). It will discuss the evolution of the regulatory framework and associated risk assessment tools and how knowledge has shaped this. it will look to highlight the remaining challenges, including in particular the analytical challenges of this ultra trace analysis paradigm we are in.  

Presented by Andrew Teasdale, Principal Consultant at Nelson Labs

Followed by a live Question and Answer session

Sponsored by Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,000 customers across 13 facilities in the United States, Mexico, Asia, and Europe.  We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations.  We have over 900 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance.  Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation.  We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.