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FDA EMEA GMP Approval of Medical Products Regulatory Affairs Quality Management Validation Platform Strategies Biosimilar Approval
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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 deals with validation parameters and its determination in accordance to current directives. Also GMP validation procedure and software validation is demonstrated.
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.
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.
This seminar deals with current strategies of formulation development. Here case studies for therapeutic agents from different leading companies will show that there is no perfectrecipe for an optimal formulation.
This seminar illustrates biosimilar production and its hazards. Examples from industry and necessities of compliance in biosimilar production are demonstrated.
This seminar reveals current strategies of global players for successfull implementationof biocatalysis and fermentation to achieve higher yield and more sustainability with newinnvations in biotech.
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