GMP for Excipients - Live Online Training

Wednesday, 25 June 2025 13.00 - 16.00 h

Course No. 21801

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Speakers

Emerich Grassinger

Emerich Grassinger

Takeda

All times mentioned are CEST.

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 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.

Programme

GMP for Excipients - Live Online Training

Seminar Programme as PDF

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,-

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

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
Further dates on-site
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Further dates online
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Recording
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Do you have any questions?

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

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023