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FDA EMEA GMP Regulatory Affairs Quality Management Approval of Medical Products Validation US legislation Petrochemistry Fill & Finish
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 optimal application of templates for individual risk assessment. Here implementation of suitablein-process controls lead to improved discoverability of potential mistakes.
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