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FDA EMEA GMP Approval of Medical Products Regulatory Affairs Quality Management Validation Business Models Generics Platform Strategies
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 deals with definitions of platform concepts which have been successfully adopted by leading pharmaceutical companies. This compilation will help to create ownbusiness strategies in accordance to lean management principles.
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