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EMEA FDA GMP Quality Management Approval of Medical Products Regulatory Affairs Validation Business to business CE-Label Filling
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 regulatory affairs in Good Manufacturing Practice directedby US agency FDA. Relevant guidelines for compliance and documentation requirements for development and production are 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.
This seminar illustrates biosimilar production and its hazards. Examples from industry and necessities of compliance in biosimilar production are demonstrated.
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