Course No 15620
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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. 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
ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation.
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, 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.
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 of the Manufacturing Authorisation Holders. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.