ICH Q7 Training Courses

The ICH Q7 Week will be held from 21 to 25 November 2022

Objectives

These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7. The contents of the guideline will be explained step by step and practical advices will be given on how to fulfil the requirements of ICH Q7. You will also get to know the key principles of risk management, quality systems and development and manufacture of APIs as they are laid down in ICH Q9, Q10 and Q11 and the ICH Q7 Q&A Document.

For example, you will learn:

  • at which stage of production GMP compliance is to be applied,
  • how to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, change control, failure investigation etc.,
  • how to use a risk-based approach within the concept of supplier qualification,
  • how to link material attributes and process parameters to drug substances CQAs,
  • what has to be considered in order to be prepared for a GMP inspection.

Target Group

These education courses are designed for all persons involved in the manufacture of APIs (either chemically or by cell culture/fermentation) especially for persons from production, quality control, quality assurance and control, technical and regulatory affairs departments as well as for Qualified Persons and Auditors. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.

Testimonials of participants attending one of the previous ICH Q7 Weeks

“Thank you for great talks and excellent organisation!“
Dr. Michel Van Overschelde, Johnson & Johnson Pharmaceutical RD Division Janssen Pharmaceutica N.V.

“Excellent presentations today. Really enjoyable day watching the roleplays well done. I have obtained great ideas and taken lots of great notes for my training.“
Joanne Johnston, Zoetis Rathdrum

“Good opportunity at the role plays to see audit situations, good to have interactive communication.“
Farina Neuwirth, CU Chemie Uetikon GmbH

„It’s really good experience by interacting with experienced faculty and learned a lot during training sessions.
It’s really good about time management during sessions and the host of the Live Online Training supported a lot to get the answers from trainers for all my questions.”
Parasuramu Kamma

Download the Programme

 

 

 
Download the ICH Q7 Week Programme as PDF.

Contact

Contact us

If you have any questions or suggestions, please contact us. We will be happy to help you with your concerns.

Concept Heidelberg GmbH

Rischerstraße 8

DE 69123 Heidelberg

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