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EMEA FDA GMP Approval of Medical Products Regulatory Affairs Quality Management Validation Six Sigma White Biotech Business Models
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 validation parameters and its determination in accordance to current directives. Also GMP validation procedure and software validation is demonstrated.
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