Emerich Grassinger
Takeda
Referent:innen
Dr Franz Schönfeld
GMP Inspektor
Zielgruppe
This Live Online Training is prepared for personnel from Quality Control, Quality Assurance, and production who want to gain a better understanding of the requested regulatory requirements for Excipients, as well as having an efficient planning, execution, and evaluation of a formalized risk assessment.
Zielsetzung
This Live Online Training provides regulatory requirements and recommendations (WHO, ICH, EU) for the handling and use of Excipients compared to Active Pharmaceutical Ingredients (APIs). The use, creation and implementation of a formalized Risk Assessment, which is common practice in the pharmaceutical industry nowadays, is a good tool to fulfil the GMP requirements. Therefore, the needed measurements and checks will be explained and the evaluation of the risks will be discussed.
Programm
EU GMP Requirements for Excipients – View of an Inspector
- Introduction and Background
- Legal requirements: Supplier qualification and existing certification Programmes
- Expectations of the authorities
- Observations and findings
Formalized Risk Assessment for Excipients
- Quality Risk Management (ICH Q9)
- Formalized risk assessment for ascertaining the appropriate GMP for excipients
- In which cases do you need a formalized risk assessment?
- Which risks need to be considered?
- How to do the evaluation?
- Which measurements could be useful?
- Which checks need to be performed?
- Risk control, risk review, risk communication
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 € 690
APIC Members € 740
Non-ECA Members € 790
EU GMP Inspectorates € 690
The 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(0)62 21/84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald (Organisation Manager) +49(0)62 21/84 44 51, trohwald@concept-heidelberg.de.
Datum & Uhrzeiten
Tuesday, 03 Feb. 2026, 13.00 h – 17.00 h CET
Teilnahmegebühr
| ECA-Member*: | € 690,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 690,- |
| 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
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E-Mail: info@concept-heidelberg.de
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