ICH Q7 Training Courses


The ICH Q7 Training 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


Optional ICH Q7 Training Courses

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


You may combine one of the ICH Q7 Training Courses with the

During the ICH Q7 Auditor Training Course we 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, the Training Course will provide 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.