Root Causes
Which root causes for nitrosamine impurities should be considered
pharma
Nitrosamine Impurities MasterClass - US edition
08-09 FEBRUARY 2027
08-09 FEBRUARY 2027Virtual
Various nitrosamines (such as NDMA, NDEA, and others) have been detected in nearly every drug product containing a sartan derivative as an API. An EMA Questions & Answers document describes various potential sources of nitrosamine contamination.
27-28 April, 2026, Virtual
STARTING TIME EST 10:00 A.M. | PST 07:00 A.M. | UTC 3:00 P.M.
Key learnings
Nitrosamine Contamination
Which practical approaches can be applied to assess the risks related to potential nitrosamine contamination
Safety Aspects
Which safety aspects need to be taken into account regarding nitrosamine impurities in drug products
Pharmacopoeia
Activities of the Pharmacopoeia concerning mutagenic impurities, focusing on nitrosamines
Trusted by over 17,000 delegates across leading companies
Overview
Various nitrosamines (such as NDMA, NDEA, and others) have been detected in nearly every drug product containing a sartan derivative as an API. An EMA Questions & Answers document describes various potential sources of nitrosamine contamination. In September 2019, the EMA published a press release advising pharmaceutical companies on steps to avoid nitrosamines in human medicines. In another document released around the same time, marketing authorization holders were requested to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesized APIs. Consequently, in cases of contamination with nitrosamines, marketing authorization holders are required to file a variation application.
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Meet the expert
Trainer
Dr. Ralph Nussbaum
Dr. Ralph Nussbaum joined Omega Pharma Manufacturing Germany in 2024 as Head of Quality & Qualified Person. Before, he has been Vice President Quality Management and Managing Director, Member of the Board at Auregen BioTherapeutics GmbH in Reutlingen. Dr. Ralph Nussbaum was Market Segment Leader Pharma and Site Manager at SYNLAB Analytics & Services Germany GmbH in Aachen from 2017 to 2020. Dr. Ralph Nussbaum is a chemist and worked in quality control at Gruenenthal GmbH. He gained further professional experience at CarboGen Laboratories AG as Manager Quality Assurance. From 2003 to 2017, he was Managing Director of Analytical Services.
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WHO SHOULD ATTEND
This live online training is aimed at all personnel involved in the development of drug substances and drug products, from scientific staff to laboratory heads in research and development. The needs of laboratory managers, supervisors, and analysts in pharmaceutical quality assurance and quality control departments will also be addressed. Furthermore, this training will cover regulatory requirements, making it applicable to individuals working in regulatory affairs.
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