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.
Objectives
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.
Programme
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
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 € 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.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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