Dr Ulrich Rose
Straßburg
Referierende
Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Osama Chahrour
Astra Zeneca
- 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
Programm
Part II: Nitrosamine Impurities
Practical Approaches for assessing the Risk of Nitrosamines and other Mutagenic Impurities in Drug Substances and Drug Products
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
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.
Weitere Informationen
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.
Contacts
Questions regarding content:
Ms Anne Günster (Operations Director), +49 62 21 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49 62 21 84 44 25, bauer@concept-heidelberg.de
Datum & Uhrzeiten
The Impurities Workshop Part II:
Wed, 28 October 2026, 9:00 – 15:45 h
Wed, 28 October 2026, 9:00 – 15:45 h
The Impurities Workshop Part III:
Thu, 29 October 2026, 9:00 – 14:00 h
Thu, 29 October 2026, 9:00 – 14:00 h
All times mentioned are CET
Teilnahmegebühr
| ECA-Member*: | € 1490,- |
| Non ECA Member*: | € 1590,- |
| EU/GMP Inspectorates*: | € 1190,- |
| APIC Member Discount*: | € 1540,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
