ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis - Live Online Training
24-26 November 2025
Course No. 21919
Speakers
Tim Ohlrich
gempex
Peter Mungenast
Formerly Merck
Dr Thomas Becker
Dr. Thomas Becker Pharma & Biotech Consulting
Francois Vandeweyer
VDWcGMP Consulting
Dr Markus Dathe
F. Hoffmann-La Roche
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
All times mentioned are CET
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, 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.
Choose between two parallel GMP education courses according to your field of interest:
ICH Q7 Compliance for APIs manufactured by Chemical Synthesis or
ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation
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!
Target Group
These Live Online Training 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, 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.
Technical Requirements
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.
Testimonials
Seminar Programme as PDF