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GMP Approval EMEA FDA Quality Management Medical Products Software Validation OEM CE-Label Lyophilisation
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 current methods in risk management and strategies for optimalapplication of templates for individual risk assessment. Here implementation of suitablein-process controls lead to improved discoverability of potential mistakes.
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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