ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation - Live Online Training

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, Q11 and the ICH Q7 Q&A Document.

For example, you will learn

Choose between two parallel GMP education courses according to your field of interest:

Take advantage of combining one of the ICH Q7 Courses with the Auditor Training Course and receive the ECA Certifcate “QA Manager and Auditor for APIs”.

The ICH Q7 Auditor Training Course will inform you about the general advice on Good Auditing Practices included in the APIC “Auditing Guide” and the APIC Third Party Audit Programme. In addition to the training of the communication skills, you will be provided with assistance on what to focus on during an API Audit and on the current “state of the art” from an industry perspective. Moreover you will learn about the key principles of writing a professional audit report.

 

As the number of participants for the Auditor Training Course is strictly limited early booking is recommended!

We use Webex for our live online training courses and webinars. At 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.

Participants intending to obtain the APIC Auditor Certification: The Role Plays are mandatory for all participants intending to obtain the APIC Auditor Certification. Due to this fact, please make sure that you will have a webcam, microphone (preferably headset), a constant internet connection (preferably via LAN) and join the Webex session via the Webex Application (not via the temporarily browser application). Please note that during the Role Plays other participants will be able to view your chosen name, see your picture and hear your voice.