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FDA EMEA GMP Regulatory Affairs Quality Management Approval of Medical Products Validation ISO 9001 Galenic US legislation
This seminar delivers insider information on setting up quality management systems compliant to ISO 9001 with several templates for own establishment. Furthermore classification of medical products due to international guidelines and following approval process is illustrated.
This seminar deals with assembly of technical documentations and gives advices forcompliant documentation structures required within quality management systems.Furthermore generation of stability data for identification of expiry dates is illustrated.
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