Quality Management Manual of a fictive Company

All participants of the ICH Q10 Training Course offered by the ECA Academy will receive some additional information as part of their conference documentation.The Quality Management Manual of the fictive company “Example” does not only take into consideration the quality assurance system (QA System) as required by the GMP regulation but also the requirements of the international standards EN ISO 9001: 2000 on Quality Management Systems and EN ISO 13485: 2003 “Quality Management Systems – Medical Devices – Requirements for Regulatory Purposes”. The Quality Manual was developed by a task force of the German Medicines Manufacturers Association. The content is structured according to ISO 9001. In the appendix of the publication you will find exemplary job descriptions, e.g. for the Qualified Person, Head of Production and Head of Quality Control. Further examples include forms for the review by the management and a process flow chart.

The participants will also receive a matrix which compares the ICH Q10 Guideline and the international standard on quality management ISO 9001. This matrix is helpful to identify areas that are not covered in one of the two documents. Please read more about the ICH Q10 Training Course on 9-10 October 2014 in Heidelberg. The training course can be booked in combination with the ICH Q9 Training Course. In this case a reduced fee will apply.

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