The Impurities Workshop Part II and III - Live Online Training
Practical Approaches for Assessing the Risks of Impurities
28/29 October 2026
Course No. 22760
Speakers
Dr Ulrich Rose
Straßburg
Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Practical Approaches for assessing the Risk of Nitrosamines and other Mutagenic Impurities in Drug Substances and Drug Products
Elemental Impurities - Practical Approaches for Identification and Control
Programme
Part II: Nitrosamine Impurities Practical Approaches for assessing the Risk of Nitrosamines and other Mutagenic Impurities in Drug Substances and Drug Products
European Pharmacopoeia Activities (Policy) on Mutagenic Impurities with Focus on Nitrosamines
Ph. Eur. General policy on DNA reactive impurities
Control of Nitrosamines in Ph. Eur.
Changes in individual and general monographs following the Sartan case
New general chapter on control of nitrosamines
Root Causes for Nitrosamine Impurities and other Mutagenic Impurities – Practical Approaches to Assess the Risks
Development of a systematic risk based approach
Key factors and the development of a decision tree
API
Drug Product
Packaging
Case Study: Conducting a Nitrosamine Risk Assessment - Evaluation through Case Studies
Several case studies will be presented and a risk assessment for different scenarios is shown taking into account e.g. manufacturing equipment, dosage form of the drug product, etc.
Nitrosamines and other Genotoxic Impurities – Authorities' Expectations and Dossier Requirements
The assessor’s approach: principles of toxicological assessment
Structural alerts
Limits and Permitted Daily Exposure
The ALARP principle
Examples of low daily dose drug substances
Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
Nitrosamines – the Valsartan case
Potential mutagenicc residual solvents
Impurities derived from metal catalysts
Part III: Elemental Impurities
Practical Approaches for Identification and Control
European Pharmacopoeia Activities (Policy) on Elemental Impurities – an Update
Implementation of Q3D in Ph. Eur.
Changes in individual and general monographs
Harmonisation of general chapter 2.4.20
Second phase for revision of excipient monographs
Control Strategies for Elemental Impurities in Final Dosage Forms – Case Studies
Utilisation of data as part of an integrated EI risk assessment process
Potential sources of elemental impurities in the finished product
API
Equipment
Container-closure system
Excipients
Conclusions
Workshop: Conducting a Risk Assessment
In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 1,490 APIC Members € 1,540 Non-ECA Members € 1,590 EU GMP Inspectorates € 1,190 The conference fee is payable in advance after receipt of invoice
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
