GMP for Excipients - Online Training Recording

Course No. 22485

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Speakers

Emerich Grassinger

Emerich Grassinger

Takeda

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.

Target Group

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 Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Programme

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?
Recording from 25 June 2025
Duration of Recording: 1h 47min

ECA-Member*: € 590,-
Regular Fee*: € 690,-
EU/GMP Inspectorates*: € 590,-
APIC Member Discount*: € 640,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Additional dates on-site
Additional dates on-site
not available
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Additional dates online
not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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