Ralf Gengenbach, gempex, Germany
Andy Bailey, ViruSure, Austria
Markus Dathe, F. Hoffmann-La Roche, Switzerland
Paul Lopolito, Steris Corporation, USA
Peter Mungenast, Merck KGaA, Germany
Rob Slobbe, Philips Image Guided Therapies, The Netherlands
Paul Stockbridge, Stockbridge BioPharm Consulting, UK
Francois Vandeweyer, VDWcGMP Consultancy, Belgium
Peter C. Zimmermann, Iskom, Germany
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.
Combine the ICH Q7 Courses with the Auditor Training Course
Take advantage of combining your ICH Q7 education course on Compliance for Chemical APIs or Compliance for Biotech APIs with an ICH Q7 Auditor Training Course.
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.
As the number of participants for the Auditor Training Course is strictly limited early booking is recommended!
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, 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.
Compliance Session Part 1 – Management Process