Emerich Grassinger
Takeda
Referent:innen
All times mentioned are CEST.
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.
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.
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 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.
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
Regulations and Guidelines for Excipients
- Regulations (European regulations, WHO, Pharmacopoeias)
- Requirements for Excipients (compared to APIs)
- Quality Risk Management (ICH Q9)
- Formalized Risk Assessment for ascertaining the appropriate GMP for Excipients
Formalized Risk Assessment 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?
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
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Weitere Termine online
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Aufzeichnung nicht verfügbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
Sonderkonditionen DB BahnTeilnehmerstimmen - das sagen andere über unsere Seminare:
