Dr Ulrich Rose
Straßburg
Referent:innen
Dr. Andrew Teasdale
Astra Zeneca
All times mentioned are CET.
Zielsetzung
In Part III of the Impurities Workshop the key principles of the ICH Q3D Guideline on elemental impurities will be highlighted. You will get to know the essential aspects and approaches of how to assess the risks and control elemental impurities in drug substances, drug products and excipients.
You will learn
You will learn
- what has to be considered with respect to the drug substance monographs of the European Pharmacopoeia,
- how to perform a risk assessment in order to establish a control strategy for elemental impurities,
- how the route of administration and the duration of exposure affect the limits of elemental impurities
Hintergrund
In November 2014 the ICH Q3D Guideline for Elemental Impurities was published as Step 4 document. This document outlines
- the evaluation of the toxicity data for potential elemental impurities
- the PDEs for each element of toxicological concern
- the basis for an EI risk assessment and the key factors for evaluation.
- the development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE
Meanwhile, ICH Q3D was revised twice, regarding Cadmium Inhalation PDE (ICH Q3D(R1); Step 2 document) and cutaneous and transdermal products (ICH Q3D(R2); Concept Paper).
Zielgruppe
This Live Online Training is addressed to all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.
Dates / Technical Requirements / Presentations / Certificate
Dates
The Impurities Workshop Part I: General Strategies for Identification and Control of Impurities
18 November 2025, 08.30 – 17.15 h CET
The Impurities Workshop Part II: Nitrosamine Impurities
19 November 2025, 09.00 – 16.30 h CET
The Impurities Workshop Part III: Elemental Impurities
20 November 2025, 09.00 – 13.45 h CET
18 November 2025, 08.30 – 17.15 h CET
The Impurities Workshop Part II: Nitrosamine Impurities
19 November 2025, 09.00 – 16.30 h CET
The Impurities Workshop Part III: Elemental Impurities
20 November 2025, 09.00 – 13.45 h CET
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 trainings 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.
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.
Programm
Gesamtes Programm als PDF herunterladen
Part III: Elemental Impurities
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.
| ECA-Member*: | € 690,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 595,- |
| APIC Member Discount*: | € 740,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung 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
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